BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 12301141 · Received August 10, 2021

    Report

    Report Number
    0001825034-2021-02352
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    January 11, 2021
    Report Date
    October 28, 2021
    Product Code
    KWS
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02351-1. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT NO DAMAGE WAS NOTED FROM THE PROVIDED PICTURE OF THE HUMERAL BEARING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. OPERATIVE AND PATHOLOGY REPORTS WERE REVIEWED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2019, SUBSEQUENTLY REVISED ON (B)(6) 2021 DUE TO PAIN AND SUSPECTED IMPLANT FRACTURE ON IMAGING. DURING THE REVISION INFLAMMATION FOUND WITH NO DEVICE FRACTURE. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02351. MEDICAL PRODUCTS: ITEM#: TI-115310, COMP VRSDL GLNSPR 36MM TI; LOT#: 171290. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE CUSTOMER WILL NOT RETURN PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REVERSE ARTHROPLASTY FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT BEGAN HAVING PAIN DURING ACTIVITY AND WAS REVISED APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS DUE TO PAIN AND IMAGINING DISPLAYING A POSSIBLE FRACTURE OF IMPLANT. DURING THE REVISION INFLAMMATION FOUND WITH NO DEVICE FRACTURE. THE GLENOSPHERE AND BEARING WAS EXCHANGED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201408 ARCOM XL 44-36 STD HMRL BRNG SHOULDER PROSTHESIS/EXTREMITIES KWS N/A 756010

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R SEE H10 NARRATIVE.