BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 8843804 · Received July 30, 2019

    Report

    Report Number
    0001825034-2019-03193
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 12, 2019
    Report Date
    November 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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: A1, A2, A3, B3, B4, B5, B7, D1, D2, D4, D6A, D10, E1, E2, E3, G3, G4, H2, H3, H6 D10: REF (B)(4) LOT 055560 M2A SHELL REF (B)(6) LOT 217800 TAPERLOC FEMUR REF (B)(6) LOT 220820 M2A TAPER ADAPTER

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES PAIN, LLD, ROM, HO, AND SUBSIDENCE AS REPORTED AND ALL COMPONENTS WERE REPLACED WITHOUT COMPLICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO PAIN, LEG LENGTH DISCREPANCY, AND RANGE OF MOTION COMPLICATIONS. DURING THE REVISION, EXTENSIVE HETEROTOPIC OSSIFICATION WAS REMOVED. THE FEMORAL STEM WAS WELL-FIXED BUT HAD SUBSIDED DEEP INTO THE FEMUR. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE STEM AND WAS REPAIRED WITH CERCLAGE WIRES. NO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: UNK, UNK LINER, LOT: UNK, PART: UNK, UNK CUP, LOT: UNK, PART: UNK, UNK HEAD, LOT: UNK, PART: UNK, UNK STEM, LOT: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: LINER: 0001825034-2019-03190, CUP: 0001825034-2019-03191, STEM: 0001825034-2019-03192, HEAD: 0001825034-2019-03193.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE, AND SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634681 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 828040
    634682 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 828040

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R SEE H10| SEE H10 NARRATIVE