BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR 40MM GLENOSPHERE STD COCR

    MDR report key: 15904375 · Received December 2, 2022

    Report

    Report Number
    0001822565-2022-03334
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 8, 2022
    Report Date
    March 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868231254
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-03335, 0001822565-2022-03336. MEDICAL PRODUCTS: ITEM#: 110031427, CR VIVACIT-E 40MM BRNG STD; LOT#: 64597882, ITEM#: 110031405, MINI TRAY STD COCR +6 OFFSET; LOT#: 64809025. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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: 0001822565-2022-03335-1, 0001822565-2023-00459-1. H6: COMPONENT CODES: MECHANICAL (G04) - HEAD. VISUAL EXAMINATION OF THE PROVIDED PICTURES VERIFIES THE PART AND LOT NUMBERS. IT IS CONFIRMED THAT THE GLENOSPHERE WAS SET TO C. BIOLOGICAL DEBRIS PRESENT ON ALL PRODUCT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BILATERAL REVERSE-TYPE SHOULDER ARTHROPLASTIES ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE, DISLOCATION, IMPLANT LOOSENING, OR OTHER ABNORMALITY. IMPLANT FIT AND ALIGNMENT ARE MAINTAINED. BONE QUALITY APPEARS MILDLY OSTEOPENIC. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION DUE TO DISCOMFORT AND CLICKING OF IMPLANTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796583 CR 40MM GLENOSPHERE STD COCR SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 110030776 64973437 00887868231254

    Patients

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