BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 46B

    MDR report key: 8803933 · Received July 18, 2019

    Report

    Report Number
    0001825034-2019-03093
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 12, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE REVIEWED AND CONFIRMED SUPERIOR DISLOCATION OF THE FEMORAL HEAD AND IDENTIFIED A BONY DEFORMITY OF THE LEFT SUPER ACETABULAR REGION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. CONCOMITANT MEDICAL REPORTS: ITEM NUMBER: 110003625, ITEM NAME: BIOLOX DELTA CERAMIC LINER, LOT #: 3396340. ITEM NUMBER: 650-1159, ITEM NAME: BIOLOX DELTA CERAMIC FEMORAL HEAD, LOT #: 3493679. ITEM NUMBER: 51-108040, ITEM NAME: TAPERLOC FEMORAL STEM, LOT #: 3608395. FOREIGN REPORT SOURCE: (B)(6). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE US, BUT IS SIMILAR TO A DEVICE CLEARED UNDER K121874. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION 1 DAY POST-IMPLANTATION DUE TO RECURRENT DISLOCATION AND A MALPOSITIONED ACETABULAR SHELL. DURING THE PROCEDURE, THE ACETABULAR SHELL WAS REPOSITIONED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598594 G7 BONEMASTER LTD ACET SHL 46B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6401724

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention