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TOTAL RIGHT HIP REPLACEMENT HOWMEDICA OSTEONICS Reports 1998-2010
Medical Device Brand Name: CITATION
Medical Device Generic Name: TOTAL RIGHT HIP REPLACEMENT
Medical Device Manufacturer Name:HOWMEDICA OSTEONICS


TOTAL RIGHT HIP REPLACEMENT HOWMEDICA OSTEONICS Report # 421801
PT HAD A TOTAL RIGHT HIP REPLACEMENT. DURING THE NEXT YEAR THE HIP SLIPPED OUT OF JOINT 7 TIMES. EACH TIME IT HAPPENED, PT HAD TO CALL 911 FOR AN EMERGENCY RUN TO A LOCAL HOSP. BECAUSE OF THESE PROBLEMS, DR DECIDED TO DO SOME "EXPLANATORY" SURGERY TO DEERMINE THE PROBLEM AND TRY TO CORRECT THE SAME. THE PROBLEM WAS DETERMINED AND WAS CORRECTED AND AT THE SAME TIME THE TOTAL RIGHT HIP WAS REPLACED BY A NEW TITANIUM TOTAL RIGHT HIP AND PROBLEMS SEEMED TO HAVE BEEN SOLVED. IN THE INTERIM PT WAS A 6-7 MILE A DAY WALKER BUT THE WEATHER GOT SO HOT THAT THEY QUIT WALKING FOR A WHILE UNTIL 8/02 WHEN THEY HAPPENED TO BE OUTSIDE AT 7 AM AND REALIZED THAT THE TEMP WAS IN THE LOW 70'S AND WAS IDEAL FOR MORNING WALKS. PT AROSE THE NEXT DAY AND COULD ONLY WALK ABOUT 2-3 MILES AND WHILE RETURNING HOME WHILE WALKING AT A VERY SLOW PACE THEY SUDDENLY FELL OVER ON THE BLACKTOP ROAD. PT LOOKED DOWN AT RIGHT FOOT AND TRIED TO MOVE IT BUT NOTHING HAPPENED SO THEY KNEW THAT SOMETHING HAPPENED WITH THE TITANIUM HIP. SPOUSE CALLED 911 AND PT AGAIN WENT TO THE ER OF HOSP. A REVIEW OF THE X-RAYS BY 3 DRS LED ALL 3 OF THEM TO REMARK THAT THEY COULD NOT BELIEVE WHAT THEY SAW AS THE TOP OF THE BALL BROKE OFF THE SHANK. PT FINALLY SAW DR FOR THE FIRST TIME SINCE SURGERY AND THEIR FIRST QUESTION WAS WHERE WAS THE HIP HE REMOVED. WHAT WAS THE NAME AND ADDRESS OF THE MFR BECAUSE THEY WANTED TO HAVE THE PARTS EXAMINED BY SOMEONE TO TRY AND DETERMINE THE REASON FOR THIS EXTRA STRONG METAL TO BREAK SO EASILY. PT WAS INFORMED BY THE DR THAT THE PARTS WERE GIVEN TO THE SALES REP FOR THE MFR AND PT ASSUMES THAT THEY STILL HAVE POSSESSION OF THE SAME. A YOUNG LADY PT SPOKE TO PROMISED THAT SOMEONE WOULD GET BACK TO PT AS SOON AS POSSIBLE BUT PT IS CONCERNED ABOUT WHAT MAY HAPPEN TO THE ITEMS WHICH ARE IN THEIR POSSESSION. PT REQUESTS ASSISTANCE IN DETERMINING THE CAUSE OF THE FAILURE OF THE TITANIUM HIP.

TOTAL RIGHT HIP REPLACEMENT HOWMEDICA OSTEONICS Report # 421801
ADD'L INFO REC'D FROM MFR 12/17/02: MFR HAS DETERMINED THAT A PRODUCT RECALL OF THIS AND RELATED PRODUCT LOTS IS APPROPRIATE AND WAS INITIATED ON NOVEMBER 4TH, 2002. THE FDA WAS NOTIFIED ON NOVEMBER 15TH, 2002 IN REGARDS TO THIS RECALL DESIGNATED AS 2219689-11/15/02-010-R.

TOTAL RIGHT HIP REPLACEMENT HOWMEDICA OSTEONICS Report # 421801
ADD'L INFO REC'D FROM PT 11/04/2002: RECENTLY PT PICKED UP MEDICAL RECORDS. THE LAST PARAGRAPH OF THE SAME CERTAINLY INDICATES THAT THE PROSTHESIS WAS DEFECTIVE.


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Source: Manufacturer and User Facility Device Experience Database - (MAUDE). MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. The data is updated on a quarterly basis. DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
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