BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5607861 · Received April 26, 2016

    Report

    Report Number
    0002648920-2016-00169
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    March 30, 2016
    Report Date
    May 9, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT(S): ITEM# 00-6305-050-32 XLPE 0DEG POLY LINER 505254X32 LOT# 61112363; ITEM# 00-9993-017-55 CONE A BODY 46 X 55MM NECK LOT# 60852462; ITEM# 00-9981-150-32 POROUS STEM 15.0 X 170MM BOW LOT# 60006254; ITEM# 00-6202-052-20 TM ACET SHELL 52MM MULTI LOT# 61091638. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED PATIENT UNDERWENT REVISION DUE TO RECURRENT DISLOCATION WITH METALLOSIS. PATIENT WAS ALSO NOTED WITH PSEUDOTUMOR AND BLACK FRETTING CORROSION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Additional Manufacturer Narrative · 1

    NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD REPORT FOR THE FEMORAL HEAD SHOWS NO DEVIATIONS OR ANOMALIES WERE NOTED IN THE MANUFACTURING PROCESS FOR THIS LOT. THE PART AND LOT INFORMATION FOR THE ZMR STEM AND BODY WERE NOT RETURNED, THEREFORE INFORMATION REGARDING THE MANUFACTURING PROCESS CANNOT BE DETERMINED. THE REPORTED DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE PART LOT COMBINATION OF THE REPORTED FEMORAL HEAD. IT WAS CONFIRMED THAT THE FEMORAL HEAD AND CONE BODY WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. RELEVANT MEDICAL HISTORY IS NOT KNOWN FOR THIS PATIENT. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE FOR THE TRUNNIONOSIS REPORTED CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO TRUNNIONOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ORIGINAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 13 YEARS AGO. PATIENT UNDERWENT A 3RD REVISION 11 YEARS POST ORIGINAL IMPLANTATION DUE TO COMPLAINTS OF CHRONIC DISLOCATION, ELEVATED COBALT AND CHROMIUM LEVELS, PSEUDOTUMOR/WEAR/CORROSION. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264198 VERSYS FEMORAL HEAD PROSTHESIS HIP LPH ZIMMER MANUFACTURING B.V. 61111807

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R