BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 46/FF

    MDR report key: 17601591 · Received August 23, 2023

    Report

    Report Number
    0009613350-2023-00490
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 22, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: BREXIS SHORT STEM SIZE 2 STD ITEM #0100651102 LOT#20070875. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ACCORDING TO THE INVESTIGATION THE SHELL WAS NOT INVOLVED ON THE EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00488, 0009613350-2023-00489. 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 · 0

    (B)(4). D10 ¿ BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 ITEM#00-8775-028-02, LOT#3123270; BIOLOX DELTA CERAMIC TAPER LINER, SIZE FF / 28 I.D. FOR USE WITH 46 MM O.D. SIZE FF SHELL ITEM# 00-8775-007-28, LOT#2933863. G2 ¿ FOREIGN ¿ GERMANY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00488, 0009613350-2023-00489. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    INVESTIGATION HAS DETERMINATE THAT THE SHELL IS NOT INVOLVED ON THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION, NINE (9) MONTHS THIRTEEN (13) DAYS AFTER INITIAL HIP ARTHROPLASTY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138549 ALLOFIT IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 46/FF HIP PROTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2930655

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization| R