BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHL SZ 41/54

    MDR report key: 8809894 · Received July 20, 2019

    Report

    Report Number
    0001825034-2018-04297
    Event Type
    Injury
    Date Received
    July 20, 2019
    Date of Event
    April 19, 2017
    Report Date
    August 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID THIS SUBMISSION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 15-105044, M2A TPR HI CARBON 41/32MM LNR, 912570. X11-180312, BI-METRIC/X POR NC LAT 12X140, 774930. 11-163688, 32MM M2A HI CARBON HD STD NK, 767120. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04296, 0001825034 - 2018 - 04298. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 9 YEARS POST INITIAL SURGERY DUE TO PAIN, LIMITED RANGE OF MOTION, METALLOSIS, PSEUDOTUMOR AND BONE EROSION. DURING THE SURGERY IT WAS FOUND THAT ANTERIOR CAPSULE HAD SIGNIFICANT METALLOSIS REACTION AND STAINING IN THE TISSUE. RADICAL RESECTION REMOVING THE ENTIRE ANTERIOR AND AS MUCH OF THE INFERIOR AND SUPERIOR CAPSULE. THERE WAS SIGNIFICANT METALLOSIS REACTION AROUND THE ACETABULAR IMPLANT WITH SIGNIFICANT SOFTENING AND BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603636 M2A-T UNIV 2-HOLE SHL SZ 41/54 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 801490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R