BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM HUMERAL STEM SPACER

    MDR report key: 17723411 · Received September 11, 2023

    Report

    Report Number
    0001822565-2023-02474
    Event Type
    Injury
    Date Received
    September 11, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00889024269125
    PMA / PMN Number
    K052906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS SUBFORM WILL BE VOIDED AS THIS COMPONENT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT WILL BE INVESTIGATED UNDER MEDWATCH#S: 0001822565-2023-02473 AND 0001822565-2023-02475. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-02472, 0001822565-2023-02473, 0001822565-2023-02475, 0001822565-2023-02476. D10: 40MM ÿ GLENOSPHERE CAT: 00434904011 LOT: 65243512. 14MM ÿ 130MM LENGTH HUMERAL STEM CAT: 00434901413 LOT: 65242785. 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER CAT; 00434906606 LOT: 64759532. +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE CAT: 00434902502 LOT: 64759472. INVERS/REVERS SCR SYST 4.5-48 CAT: 01.04223.048 LOT: 2940206. INVERS/REVERS SCR SYST 4.5-42 CAT: 01.04223.042 LOT: 3082070. 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THIS SUBFORM WILL BE VOIDED AS THIS COMPONENT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT WILL BE INVESTIGATED UNDER MEDWATCH#S: 0001822565-2023-02473 AND 0001822565-2023-02475.

    Description of Event or Problem · 0

    IT WAS REPORTED A THE PATIENT IS BEING CONSIDERED FOR A SHOULDER REVISION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149351 12MM HUMERAL STEM SPACER SHOULDER, PROSTHESIS HSD ZIMMER BIOMET, INC. 65473774 00889024269125

    Patients

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