BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 52MM E

    MDR report key: 13022011 · Received December 16, 2021

    Report

    Report Number
    0001825034-2021-03359
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    November 26, 2021
    Report Date
    March 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356025
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 010000996, G7 SCREW 6.5MM X 15MM, LOT#: 6788316. CATALOG#: 010000999, G7 SCREW 6.5MM X 30MM, LOT#: 6777630. CATALOG#: 010001002, G7 SCREW 6.5MM X 45MM, LOT#: 6619234. CATALOG#: 31-323230, 3.2MMX30MM RNGLC+ ACET DRL BIT, LOT#: 504230. CATALOG#: EP-200148, ACT ARTIC E1 HIP BRG 28X42MM, LOT#: 621820. CATALOG#: 110024463, G7 DUAL MOBILITY LINER 42MM, E LOT#: 193030. REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE HAS BEEN DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 23 DAYS POST IMPLANTATION DUE TO ACETABULAR FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915283 G7 OSSEOTI MULTIHOLE 52MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6979655 00887868356025

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE