BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHL 60MM

    MDR report key: 8689836 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02500
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K062995
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 15-105000, M2A TAPER 37/28MM LINER, LOT# 011240; ITEM# 162314, BI-METRIC POROUS FMRL 15X155MM, LOT# 680020; ITEM# 15-103660, 28MM M2A MOD HEAD +6MM NK, LOT# 534540. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01586, 0001825034-2019-01588.

    Description of Event or Problem · 1

    IT WAS REPORTED BILATERAL PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 18 YEARS AGO. SUBSEQUENTLY PATIENT HAS REPORTED EXPERIENCING COBALT TOXICITY (MENTAL AND PHYSICAL), PSEUDOTUMORS, BONE LOSS, MUSCLE LOSS, AND PAIN. REVISION WILL BE SCHEDULED FOLLOWING REVISION OF HIS LEFT HIP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480243 M2A-T UNIV 2-HOLE SHL 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 008720

    Patients

    Seq Age Sex Outcome Treatment
    1