BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X25 SELF-TAP

    MDR report key: 18284771 · Received December 7, 2023

    Report

    Report Number
    0001822565-2023-03502
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    October 17, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119819
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED SHELL AND SCREWS, WITH ONE SCREW FRACTURED. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. 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). D10:00625006525 ITEM NAME BONE SCR 6.5X25 SELFTAP LOT# J7167566; 00625006520 ITEM NAME BONE SCR 6.5X20 SELF-TAP LOT # J7054522; 110010261 ITEM NAME G7 OSSEOTI MULTIHOLE 46MM B LOT # 7075146; 010000980 ITEM NAME G7 FREEDOM CONST E1 LNR 32MM B LOT # 6918291 ; 802403203 ITEM NAME ZB 12/14 COCR FRDM 32MM X +3 LOT # 3001444. G2: FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565 - 2023 - 03501. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 2 MONTHS POST IMPLANTATION DUE TO SCREW FRACTURE AND SCREW PENETRATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128752 BONE SCR 6.5X25 SELF-TAP PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A J7211462 00889024119819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H PLEASE SEE H10