BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET STEM INSERTER

    MDR report key: 17346812 · Received July 18, 2023

    Report

    Report Number
    0001825034-2023-01636
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 23, 2023
    Report Date
    August 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110010244 G7 OSSEOTI 3 HOLE SHELL 52MM E LOT NUMBER 65710932. 30103605 G7 VIT E NEUTRAL LNR 36MM E LOT NUMBER 65875354 00-6250-065-30 BONE SCREW 6.5X30 SELFTAP LOT NUMBER IS J7437657 00-6250-065-15 BONE SCREW 6.5X15 SELFTAP LOT NUMBER IS J7350954 31-323230 3.2MMX30MM RNGLC+ ACET DRL BIT LOT NUMBER IS 66040951 51-107110 TPRLC 133 MP TYPE1 PPS HO 11.0 LOT NUMBER IS 7394474 650-0660 DELTA CERAMIC FEM HD 36/- 3MM LOT NUMBER IS 3136941 98-0005-000-00 HIP REVISION 2 LOT NUMBER IS UNKNOWN. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE IS DAMAGE TO THE TIP OF THE DEVICE AND THE STRIKE PLATE HAS IMPACT MARKS. THERE IS A CRACK THAT RUNS AROUND THE SHAFT OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. 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 STEM INSERTER WAS FOUND BROKEN PRIOR TO THE CASE STARTING. THERE WAS NO DELAY TO THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169551 OFFSET STEM INSERTER INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A ZB130501

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female PLEASE SEE H10.