BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD

    MDR report key: 6637335 · Received June 13, 2017

    Report

    Report Number
    0001825034-2017-03861
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 26, 2017
    Report Date
    December 5, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A MAGNUM PF CUP, CAT#: (B)(4), LOT#: 972580; TAPERLOC FEMORAL, CAT#: (B)(4), LOT#: 096390. ROOT CAUSE REMAINS UNDETERMINED. 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). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03861, 0001825034-2017-03863, 0001825034-2017-03864.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED AND OPERATIVE NOTES. INITIAL OP NOTE FOR THE RIGHT HIP SHOWS THE PATIENT WAS REVISED DUE TO DEGENERATIVE ARTHRITIS. THE HIP WAS REDUCED WITH GOOD STABILITY, LEG LENGTH AND SOFT TISSUE TENSION. REVISION OP NOTES SHOWS THAT DARK GRAYISH STAINING WAS FOUND IN THE AREA OF THE GREATER TROCHANTER. A LARGE AREA OF CYSTIC DESTRUCTION OF THE GREATER TROCHANTER WAS FOUND. A LARGE CAVITARY LESION IN THE GREATER TROCHANTER WHICH WENT DOWN TO THE FEMORAL COMPONENT AND ANTERIORLY THROUGH THE ACETABULAR COMPONENT AS WELL. THE HEAD WAS REMOVED AND AREA OF BURNISHED METAL WAS FOUND. THE CUP WAS FOUND SOMEWHAT HIGHER DEGREE OF ANTEVERSION THAN TYPICAL, BUT NOT UNACCEPTABLE AND THE INCLINATION WAS APPROPRIATE. DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    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 SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. 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

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, EXTREMELY ELEVATED COBALT AND CHROMIUM LEVELS, AND SORENESS. NOTATIONS OF PSEUDOTUMOR FORMATION AND ELEVATED SERUM METAL LEVELS WERE NOTED. DEVICES WERE REPLACED WITH BIOMET DUAL MOBILITY BEARING, BIOLOX HEAD, AND BIOLOX TAPER ADAPTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAS BEEN SCHEDULED FOR HIP REVISION DUE TO UNKNOWN REASONS APPROXIMATELY NINE YEARS POST-OP. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, EXTREMELY ELEVATED COBALT AND CHROMIUM LEVELS, AND SORENESS. NOTATIONS OF PSEUDOTUMOR FORMATION AND ELEVATED SERUM METAL LEVELS WERE NOTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418800 SELEX/MAGNUM MODULAR HEAD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 063980

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R M2A-MAGNUM CUP| TAPERLOC POROUS STEM