BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STEM

    MDR report key: 13048098 · Received December 20, 2021

    Report

    Report Number
    0001825034-2021-03369
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    December 9, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE STEM WAS NOT LISTED AS BEING REVISED THEREFORE THE SUBFORM SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). MEDICAL PRODUCT: CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 945930; CATALOG #: 115398, COMP RVS CNTRL 6.5X40MM ST/RST, LOT # 355980; CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 265360; CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 699640; CATALOG #: 115316, COMP RVRS SHLDR GLNSP +6 36MM, LOT # 171330; CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 452990; CATALOG #: XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, LOT # 875670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03368, 0001825034-2021-03370, 0001825034-2021-03371, 0001825034-2021-03372. NOT RETURNED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE STEM WAS NOT LISTED AS BEING REVISED THEREFORE THE SUBFORM SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946586 UNKNOWN STEM PROSTHESIS SHOULDER PHX ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10