BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG E1 LINER 36MM E

    MDR report key: 12916789 · Received December 2, 2021

    Report

    Report Number
    0001825034-2021-03260
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 11, 2021
    Report Date
    March 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304526761
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: CAT# 110010244 G7 OSSEOTI 3 HOLE SHELL 52MM E LOT#6964449; CAT# 52.34.0688 MATHYS HEAD (COMPETITOR) LOT# 2276691; CAT# 010000999 G7 SCREW 6.5MM X 30MM LOT#6817834; UNKNOWN MATHYS STEM (COMPETITOR) . REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED POTENTIALLY UNDER SIZED ACETABULAR CUP FOR THE SIZE OF THE FEMORAL HEAD. IN THE APPROPRIATE CLINICAL CONTEXT, THIS COULD ACCOUNT FOR RECURRENCE DISLOCATIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANOTHER REVISION SURGERY APPROXIMATELY 5 MONTHS LATER DUE TO RECURRENT DISLOCATIONS. IT IS NOTED THAT COMPETITOR PRODUCTS WERE USED WITH ZIMMER BIOMET PRODUCTS DURING THE LAST REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812745 G7 10 DEG E1 LINER 36MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6760350 00880304526761

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE