BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE 0DEG POLY LINER 505254X32

    MDR report key: 7873063 · Received September 13, 2018

    Report

    Report Number
    0001822565-2018-04869
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    March 30, 2016
    Report Date
    May 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 00801803203 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER LOT# 61111807. 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716252 XLPE 0DEG POLY LINER 505254X32 PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 61112363

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R