BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TRABECULAR METAL REVERSE SHOULDER IMPLANT

    MDR report key: 6445453 · Received March 30, 2017

    Report

    Report Number
    0001822565-2017-01937
    Event Type
    Injury
    Date Received
    March 30, 2017
    Report Date
    July 7, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TIUSANEN, H. ET AL. (2016). "RANGES OF MOTION AFTER REVERSE SHOULDER ARTHROPLASTY IMPROVE SIGNIFICANTLY THE FIRST YEAR AFTER SURGERY IN PATIENTS WITH RHEUMATOID ARTHRITIS." EUR J ORTHOP SURG TRAUMATOL, 26, 447¿452. DOI 10.1007/S00590-016-1795-6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED AS THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE JOURNAL ARTICLE PREVIOUSLY SUBMITTED WITH THIS REPORT IDENTIFIED THE "BIGLIANI/FLATOW TRABECULAR METAL" SHOULDER MANUFACTURED BY ZIMMER, INC, (B)(4). HOWEVER, AS THIS JOURNAL ARTICLE CONCERNS REVERSE SHOULDERS SPECIFICALLY, AND ZIMMER, INC DOES NOT MANUFACTURE BIGLIANI/FLATOW REVERSE SHOULDERS, IT IS ASSUMED THAT THE AUTHOR IS REFERRING TO THE ZIMMER TRABECULAR METAL REVERSE SHOULDER, WHICH IS THE ONLY REVERSE SHOULDER MANUFACTURED BY ZIMMER, INC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOLLOWING TOTAL REVERSE SHOULDER ARTHROPLASTY AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED TWELVE (12) UNKNOWN COMPLICATIONS THAT WERE REPORTED DURING SEVEN (7) YEARS OF POST-OPERATIVE FOLLOW-UP. 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
    229865 UNKNOWN ZIMMER TRABECULAR METAL REVERSE SHOULDER IMPLANT PROSTHESIS, SHOULDER HSD ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other