BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE-PIECE CUP 38MM X 56 O.D.

    MDR report key: 6407803 · Received March 15, 2017

    Report

    Report Number
    0001825034-2017-01613
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    November 19, 2015
    Report Date
    January 28, 2021
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN M2A 38MMX56MM CUP, PART # RD118856 FROM LOT 473940, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION CONFIRMED THE INNER RADIUS OF THE CUP TO BE SCUFFED AND WORN. THE RIM OF THE CUP IS SCRATCHED AND DENTED. FOREIGN DEBRIS REMAINS AFFIXED TO THE POROUS COATING. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A FEMORAL HEAD, CATALOG#: 11-173662, LOT#: 429160; MALLORY FEMORAL STEM, CATALOG#: 11-104212, LOT#: 213430. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03955 & 2017-01613).

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PROVIDE OP NOTES CONFIRMED THE COMLPAINT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS AND A RETROVERTED ACETABULAR COMPONENT. DURING THE PROCEDURE, METALLOSIS AND METAL STAINING WERE NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189919 M2A 38MM ONE-PIECE CUP 38MM X 56 O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 473940

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R