BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 9615581 · Received January 22, 2020

    Report

    Report Number
    0001825034-2020-00356
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    September 5, 2018
    Report Date
    January 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115330 COMP RVRS SHDR GLEN BSPLT +HA 791180, 118001 VERSA-DIAL/COMP TI STD TAPER 483010, 113647, COMP PRIMARY STEM 7MM STD, 939230, EB0101, TORNIER RESTRICTOR CEMENT, UNKNOWN, 6197-9-010, STRYKER CEMENT SIMPLEX P, MKY067, 6197-9-010, STRYKER CEMENT SIMPLEX P, MJY056. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03777 - 1, 0001825034 - 2019 - 03778 - 1. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. REVIEW OF THE AVAILABLE MEDICAL RECORDS/RADIOGRAPHS IDENTIFIED THE FOLLOWING: (B)(6) 2018: X-RAYS TAKEN NOTE LEFT (L) SIDE WITH SCAPULAR NOTCHING JUST BELOW THE INFERIOR SCREW OF THE L SHOULDER; HOWEVER, ALIGNMENT IS SATISFACTORY. NO EVIDENCE OF SUBLUXATION OR DISLOCATION. THE PATIENT NOTED OVERALL SATISFIED WITH OUTCOME. (B)(6) 2019: X-RAYS TAKEN ON L SIDE NOTES INFERIOR SCAPULAR NOTCHING INTO THE LATERAL PILLAR OF THE L SHOULDER; HOWEVER, ALIGNMENT IS SATISFACTORY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT SHOULDER WAS FOUND TO HAVE INFERIOR SCAPULAR NOTCHING INTO THE LATERAL PILLAR APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78311 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 432570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other