BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV RNGLC SHL 48MM/L22

    MDR report key: 6977114 · Received October 25, 2017

    Report

    Report Number
    0001822565-2017-07465
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    July 1, 2016
    Report Date
    October 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E-POLY 32MM +3 HIWALL LNR SZ22 P/N EP-108322 L/N 821500. CER BIOLOXD OPTION HD 32MM P/N 650-1056 L/N 907600. CER OPTION TYPE 1 TPR SLEVE +3 P/N 650-1067 L/N 816140. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. PICTURES WERE REVIEWED WITH HEALTH CARE PROFESSIONAL AND DEVELOPMENT ENGINEER AND CONFIRMED THAT CUP POSITION WAS RETROVERTED. DEFORMATION WAS FOUND NEAR THE FRACTURED PART INDICATING THE HIGH WALL LINER WAS SUBJECTED TO OVER LOADING. IT IS POSSIBLE THAT THE IMPLANT POSITION LED TO IMPINGEMENT AND CAUSING EXCESSIVE WEAR AND LOADING ON THE HIGH WALL LINER RESULTING IN THE FRACTURE AND DISLOCATION OF THE HEAD. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. 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

    PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY TEN MONTHS POST-IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE ACETABULAR LINER WAS NOTED TO BE FRACTURED. THE FEMORAL HEAD, ACETABULAR LINER AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758223 UNIV RNGLC SHL 48MM/L22 HIP PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 606460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R