BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY HIGH WALL 40MM F

    MDR report key: 11862342 · Received May 21, 2021

    Report

    Report Number
    0001822565-2021-01406
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    January 14, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519381
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ITEM NUMBER 010000664 ITEM NAME G7 PPS LTD ACET SHELL 54F LOT # 6803742. ITEM NUMBER 00625006530 ITEM NAME BONE SCREW SELF-TAPPING6.5 MM DIA. 30 MM LENGTH LOT# J6813932. ITEM NUMBER 00625006525 ITEM NAME BONE SCREW SELF-TAPPING6.5 MM DIA. 25 MM LENGTH LOT # J6817641. ITEM NUMBER 00625006520 ITEM NAME BONE SCREW SELF-TAPPING6.5 MM DIA. 20 MM LENGTH LOT # 64558809. ITEM NUMBER 650-1058 ITEM NAME CER BIOLOXD OPTION HD40MM 0 LOT # 3032856. ITEM NUMBER 650-1064 ITEM NAME CER OPTION TYPE 1 TPRSLEVE -6 PE 1 LOT # 3031442. ITEM NUMBER 51-108080 ITEM NAME TPRLC 133 MP T1 PPS SO8X101MM LOT # 6685818. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A DEFINITIVE ROOT CAUSE CANNOT 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. PREVIOUSLY INCORRECTLY REPORTED UNDER MFR: 0001825034 - 2021 - 00087.

    Description of Event or Problem · 1

    T WAS REPORTED THE PATIENT STATED SHE UNDERWENT A THA. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION 3 MONTHS LATER. SURGEON REPORTED THAT LINER HAD DISSOCIATED AND THERE WAS DIRECT CERAMIC HEAD CONTACT WITH SHELL, LEADING TO METALLOSIS, METALLIC DEBRIS, IMPLANT WEAR TO SHELL, AND PSEUDOTUMOR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758826 G7 LONGEVITY HIGH WALL 40MM F PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 64577165 00889024519381

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R