BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 62MM

    MDR report key: 7023608 · Received November 11, 2017

    Report

    Report Number
    0001825034-2017-10150
    Event Type
    Injury
    Date Received
    November 11, 2017
    Date of Event
    May 18, 2017
    Report Date
    August 5, 2020
    Manufacturer
    BIOMET ORTHOPEDICS LLC.
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. SURGEON NOTICED METALLIC TISSUE THAT WAS BLACK IN NATURE. THERE WERE SOME SIGNS OF TRUNNIONOSIS ON THE UNDERSURFACE OF THE FEMORAL HEAD WHEN IT WAS REMOVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND EVALUATION OF DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A M2A-38 CUP NON FLARED SZ 62MM, PART # 15-106062 FROM LOT 814010, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND LEFT OVER BONE CEMENT AND DEBRIS AFFIXED TO THE POROUS COATING. THE RIM AND INNER RADIUS ARE SCRATCHED AND SCUFFED CONSISTENT WITH A METAL ON METAL CONSTRUCT. THE FINISH OF THE INNER RADIUS HAS BECOME WORN AND DULL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: TAPERLOC POR LAT FMRL 15X150 LOT#576250 ITEM#11-103208, M2A 38MM MOD HD +3MM NK LOT#315050 ITEM#11-173663. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 REPORT: 0001825034-2017-10151.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED 12 YEARS POST-IMPLANTATION DUE TO METALLOSIS, PAIN, ADVERSE REACTIONS TO METAL IONS. BLACK METALLIC TISSUES WERE FOUND. TRUNNIONOSIS ON THE UNDERSURFACE OF THE FEMORAL HEAD WAS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND WAS FORCED TO UNDERGO A COSTLY AND PAINFUL REVISION SURGERY TO REPLACE HIS METAL ON METAL HIP DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802580 M2A-38 CUP NON FLARED SZ 62MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS LLC. N/A 814010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R