BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TPR HI CARBON 37/28MM LNR

    MDR report key: 13964680 · Received March 31, 2022

    Report

    Report Number
    0001825034-2022-00727
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    August 19, 2015
    Report Date
    April 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 15-103650- M2A-T UNIV 2-HOLE SHL 50MM- 232620, 11-103200- TAPERLOC POR LAT FMRL 5.0X130- 042600, 103532- TI LOW PROFILE SCREW 6.5X25MM- 286550, 103532- TI LOW PROFILE SCREW 6.5X25MM- 317410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00728, 0001825034-2022-00730, 0001825034-2022- 00731, 0001825034-2022-00732. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105150 M2A TPR HI CARBON 37/28MM LNR PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 810970

    Patients

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