BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAICMOD PROX HUM STM 8.5X100

    MDR report key: 9727100 · Received February 19, 2020

    Report

    Report Number
    0001825034-2020-00795
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    July 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304210837
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    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: 0001825034-2020-00733, 0001825034-2020-00734. CUSTOMER IS INDICATED TO BE REVISED, BUT REVISION SURGERY DATE HAS YET TO BE SCHEDULED. CONCOMITANT MEDICAL PRODUCTS: PART #115330 LOT #524630. PART #115384 LOT #364490. PART #180509 LOT #211690. PART #180509 LOT #442880. PART #180510 LOT #918970. PART #180510 LOT #918970. PART #417200 LOT #0000633939. PART #402439 LOT #628120. PART #402439 LOT #632240. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. MMI REVIEW OF XRAYS HAD SIGNIFICANT FINDINGS OF LOOSENING, DISLOCATION, OSTEOPENIA, RADIOLUCENCY, AND OSTEOLYSIS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 HAS BEEN REPORTED PATIENT UNDERWENT RIGHT REVERSE SHOULDER ARTHROPLASTY 9 YEARS AGO. SUBSEQUENTLY PATIENT IS INDICATED TO BE REVISED DUE TO DISLOCATION, LOOSENING, AND MIGRATION, BUT SURGERY HAS YET TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190752 MOSAICMOD PROX HUM STM 8.5X100 PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI 926110 00880304210837

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other