BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 7023607 · Received November 11, 2017

    Report

    Report Number
    0001825034-2017-10151
    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. REPORTED EVENT IS AN ADVERSE EVENT BUT NOT A PRODUCT PROBLEM. 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 38MM MOD HD +3MM NK, PART # 11-173663 FROM LOT 315050, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE OUTER RADIUS TO BE SCRATCHED AND SCUFFED CONSISTENT WITH A METAL ON METAL CONSTRUCT. BLACK DEBRIS WAS OBSERVED WITHIN THE TAPER. SEM ANALYSIS: OPTICAL IMAGING OF THE TAPER OF THE MODULAR HEAD SHOWED EVIDENCE OF DARK AND LIGHT-COLORED DEPOSITS ON THE TAPER SURFACE QUANTITATIVE EDS ANALYSIS OF THE TAPER SURFACE SHOWED COMBINATIONS OF: BIOLOGICAL MATERIAL CONTAINING SOME OR ALL OF THE ELEMENTS C, O, P, S, AND CA. COCRMO SUBSTRATE MATERIAL THAT SHOWED ELEVATED LEVELS OF CR, MO, AND O, POSSIBLY EVIDENCE OF CORROSION PRODUCTS. TITANIUM, POSSIBLY TRANSFER FROM THE STEM TAPER. EDS ANALYSIS OF A NON-TAPER REGION OF THE HEAD WAS CONSISTENT WITH COCRMO ALLOY 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-38 CUP NON FLARED SZ 62MM LOT#814010 ITEM#15-106062. 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 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-10150.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. SURGEON NOTICED METALLIC TISSUE THAT WAS BLACK IN NATURE. THERE WERE SOME SIGNS OF TRUNIONOSIS ON THE UNDERSURFACE OF THE FEMORAL HEAD WHEN IT WAS REMOVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802579 M2A 38MM MOD HD +3MM NK HIP PROSTHESIS KWA BIOMET ORTHOPEDICS LLC N/A 315050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R