BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X18X53 HUM HEAD

    MDR report key: 13624682 · Received February 28, 2022

    Report

    Report Number
    0001825034-2022-00372
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    November 30, 2021
    Report Date
    March 1, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304212220
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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:0001825034-2021-03417,0001825034-2021-03418. COMCOMITANT MEDICAL PRODUCTS: ITEM# 113954; LOT# 996800, ITEM# PT-113950; LOT# 241890, ITEM# 118001; LOT# 256620, ITEM# 115330; LOT# 734280, ITEM# 405889; LOT# 321360, ITEM# 405883; LOT# 291840, ITEM# 405800; LOT# 579190, ITEM# 115395; LOT# 346230, ITEM# 180554; LOT# 705840, ITEM# 180550; LOT# 464210, ITEM# 180552; LOT# 697300, ITEM# 180550; LOT# 787440, ITEM# 118001; LOT# 386740, ITEM# 115310; LOT# 244620, ITEM# 110031424; LOT# 64980771, ITEM# 110031399; LOT# 65142051, ITEM# 110004347; LOT# 770440, ITEM# 115736; LOT# 866520R, ITEM# 20-8000-000-11; LOT# 63706262.REPORT SOURCE:FOREIGN - EVENT OCCURRED IN (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED MEDICAL RECORDS. RADIOGRAPHS IDENTIFIED MODERATE-SIZED PERIPROSTHETIC LUCENCY SURROUNDING GLENOID SCREW, CONSISTENT WITH LOOSENING AND/OR INFECTION. ASIDE FROM THE LUCENCY, REMAINING BONE QUALITY IS NORMAL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE EVENT. A DEFINITIVE ROOT CAUSE COULD NOT 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 REVISION SURGERY APPROXIMATELY FOUR (4) YEARS AND ONE (1) MONTH POST-IMPLANTATION DUE TO ROTATOR CUFF FAILURE AND LOOSE GLENOID COMPONENT. SURGEON STATED THAT AT THE TIME OF THE PRIMARY IMPLANTATION, THE PATIENT HAD UNDIAGNOSED INFLAMMATORY ARTHROPATHY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942728 VERSA-DIAL 46X18X53 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED MBF ZIMMER BIOMET, INC. NI 594640 00880304212220

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R SEE NARRATIVE IN H10