BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A HI CARBON HD STD NK

    MDR report key: 12093088 · Received June 30, 2021

    Report

    Report Number
    0001825034-2021-01935
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 14, 2021
    Report Date
    October 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. VISUAL INSPECTION OF THE PROVIDED PICTURES IDENTIFIED BIO DEBRIS AND BLOOD ON THE SHELL. THERE WERE SOME SCRATCHES ON THE INNER DIAMETER ON THE METAL LINER. NO DEBRIS WAS IDENTIFIED INSIDE THE HEAD TAPER. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. VERY LIMITED INFORMATION WAS PROVIDED AND THE REVIEW IDENTIFIED ARMD, ADVERSE REACTION OF METAL DEBRIS WITH PAIN AND WEAKNESS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 103535 TI LOW PROFILE SCREW 6.5X40MM 707940; 103534 TI LOW PROFILE SCREW 6.5X35MM 394800; 15-103684 M2A-T UNIV 2-HOLE SHL SZ 41/54 056120; 103533 TI LOW PROFILE SCREW 6.5X30MM 937120; 15-105044 M2A TPR HI CARBON 41/32MM LNR 080230; 11-163688 32MM M2A HI CARBON HD STD NK 404450; 103206 TAPERLOC POR FMRL 12.5X145 247230. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE SURGEON DIDN'T APPROVE FOR RETURN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 01933, 0001825034 - 2021 - 01934, 0001825034 - 2021 - 01935.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY APPROXIMATELY 13 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 WEEKS AGO AS THE SURGEON CLAIMS THE PATIENT WAS EXPERIENCING METAL REACTION RELATED ISSUES. 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
    990831 32MM M2A HI CARBON HD STD NK PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 404450

    Patients

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