BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM HEAD

    MDR report key: 7805689 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-08390
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    February 13, 2018
    Report Date
    August 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; H2; H3; H6. DEVICE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND PITTING ALL AROUND THE RADIUS OF THE HEAD. THE OUTER RADIUS IS ALSO SCRATCHED AND SCUFFED. THE HEAD REMAINS ASSEMBLED WITH THE INSERT. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME 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 · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO PAIN AND ELEVATED ION LEVELS. REVISION OPERATIVE NOTES STATED ESTIMATED BLOOD LOSS OF LESS THAN 100ML. IT WAS ALSO NOTED ALL OF THE SOFT TISSUE WAS CAREFULLY EXAMINED INCLUDING THE ANTERIOR CAPSULAR TISSUE IN THE HIP ABDUCTORS AND SHOWED NO EVIDENCE OF METALLOSIS, OR AVASCULAR LYMPHOCYTIC RESPONSE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: US157848, ITEM NAME: M2A-MAGNUM CUP, LOT #: 756260, ITEM NUMBER: 14-103200, ITEM NAME: TAPERLOC FEMORAL STEM, LOT #: 126670, ITEM NUMBER: 39256, ITEM NAME: M2A-MAGNUM TAPER INSERT, LOT #: 771080. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08391. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO PAIN AND ELEVATED ION LEVELS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645663 M2A-MAGNUM HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 924100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE