BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 12121273 · Received July 6, 2021

    Report

    Report Number
    0001825034-2021-01976
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    June 15, 2021
    Report Date
    April 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 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 · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00812. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SMALL AMOUNT OF PEUDO-TUMOR LIKE MATERIAL POSTERIORLY ¿ MOST OF IT WAS POSTERIOR CAPSULE. QUADRATUS WAS MISSING. GLUTEAL MUSCULATURE, INCLUDING GLUTEUS MEDIUS & MAXIMUS IN GREAT SHAPE. NO EVIDENCE OF DEEP INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TWO STAGE RIGHT HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION, UNRELATED TO INFECTION. STAGE 1 WAS PERFORMED ON AN UNKNOWN DATE AND INVOLVED DEBRIDEMENT OF A LARGE PSEUDO TUMOR WITHOUT REMOVAL OF HARDWARE. THERE IS A GAP BETWEEN THE TWO STAGES DUE TO THE PATIENT BEING COVID POSITIVE. LATER, ON THE EVENT DATE, STAGE II WAS PERFORMED, A SMALL AMOUNT OF PSEUDO TUMOR WAS REMOVED POSTERIORLY AND THE QUADRATUS WAS FOUND MISSING. THE HEAD WAS REMOVED AND A NEW HEAD, TAPER AND LINER WERE IMPLANTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 157450/ M2A-MAGNUM MOD HD/LOT # 787240. ITEM # 51-101120 / TPRLC 133 FP TYPE1/LOT # 2783624. ITEM # US157856/ M2A-MAGNUM PF CUP/LOT # 832930. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01975.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE CUP AND STEM WERE NOTED TO BE WELL FIXED. THE HEAD AND ADAPTER WERE REPLACED WITH DUAL MOBILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017604 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS HIP KWA ZIMMER BIOMET, INC. NI 966480

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10.