BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SIZE 60MM

    MDR report key: 6411615 · Received March 16, 2017

    Report

    Report Number
    0001825034-2017-01699
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    August 1, 2016
    Report Date
    March 4, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND SCRATCHING AND SCUFFING ON THE INNER RADIUS CONSISTENT WITH METAL ON METAL CONSTRUCTION. THE RIM IS GOUGED. A LARGE AMOUNT OF FOREIGN MATERIAL REMAINS STUCK TO THE POROUS COATING. SEM ANALYSIS - THE TAPER OF THE RETURNED DEVICE WAS REVIEWED VIA OPTICAL MICROSCOPY RESULTING IN A CONSENSUS MODIFIED GOLDBERG SCORE OF 4. A SCORE OF 4 CORRESPONDS TO 'DAMAGE OVER THE MAJORITY (>50%) OF THE SURFACE WITH SEVERE CORROSION ATTACK AND ABUNDANT CORROSION DEBRIS'. ADDITIONAL INFORMATION PROVIDED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - M2A FEMORAL HEAD, CATALOG#: 11-173664, LOT#: 227320. TAPERLOC FEMORAL STEM, CATALOG#: 11-103205, LOT#: 990860. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03956, 1825034-2017-01699.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE 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 THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO LOCAL ADVERSE TISSUE EFFECTS AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE OXIDATION OF THE TRUNNION AND A DISCOLORED ABNORMAL PSEUDOCAPSULE WERE NOTED. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. AN ACETABULAR LINER WAS ALSO IMPLANTED. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191808 M2A-38 CUP NON FLARED SIZE 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 373790

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R