BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL REVISION

    MDR report key: 1034151 · Received April 25, 2008

    Report

    Report Number
    1822565-2008-00200
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    July 6, 2006
    Report Date
    March 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG #00-9981-165-33, ZMR HIP SYSTEM FEMORAL BODY REVISION POROUS, LOT #68414600. EVAL SUMMARY: THE POROUS STEM HAS FRACTURED AT THE JUNCTION WITH THE CONE BODY. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PT WEIGHT, EXCESSIVE PT ACTIVITY, OR LACK OF PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NOT ALL OF THESE FACTORS ARE KNOWN FOR THIS CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MFR OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MGMT ACTIVITY HAS BEEN INITIATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THIS REPORT WILL BE AMENDED. H6: EVAL CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY PT'S ATTORNEY THAT PT UNDERWENT LEFT TOTAL HIP REPLACEMENT IN 2000. PT WAS REVISED IN EARLY 2001, AFTER A DISLOCATION AND IN 2000 AND EARLY 2001. POST-OP, PT EXPERIENCED PAIN AND AN X-RAY IN 2006, REVEALED FRACTURE OF THE FEMORAL COMPONENT OF THE HIP PROSTHESIS. PT WAS REVISED ON TWO MONTHS LATER, WHEREIN THE FEMORAL COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL REVISION HIP PROSTHESIS KWY ZIMMER, INC. NA 68417400

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R