BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR INSRTR THREADED SHAFT

    MDR report key: 11665990 · Received April 14, 2021

    Report

    Report Number
    0001825034-2021-00956
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304551602
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A G7 STR INSRTR THREADED SHAFT WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE THREADED TIP OF THE DEVICE HAD FRACTURE. THERE ARE VISIBLE DARK LINES ON THE SHAFT OF THE DEVICE FROM USE. ADDITIONAL TESTING SHOWED THE FRACTURE SURFACE FEATURES OF THE THREADED INSERTER ALIGN WITH THOSE REPORTED IN THE SUMMARY OF FAILURE ANALYSIS OF THREADED INSERTER TIP FRACTURES. THE COMMON FAILURE MODE FOR THE THREADED INSERTER TIPS PRESENTED IN THIS SUMMARY IS BENDING OVERLOAD OF THE THREADED TIP, SOME OF WHICH MAY HAVE ALSO HAD MINIMAL THREADS ENGAGED AT THE TIME OF FRACTURE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, HOWEVER, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE BEEN ATTRIBUTED TO THE EVENT. 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 DURING A TOTAL HIP ARTHROPLASTY THAT THE INSERTER THREAD WOULDN¿T ATTACH TO THE CUP AND THE IMPACTOR TO INSERT THE CUP LINER. THERE WAS NO DELAY AND PATIENT WAS NOT AFFECTED. THE RETURNED DEVICE SHOWS THE TIP WAS FRACTURED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 110010263 LOT# 6833798 G7 OSSEOTI MULTIHOLE 50MM D. CAT# 00-6250-065-40 LOT# 64710815 BONE SCREW 6.5X40 SELFTAP. CAT# 110024462 LOT# 172570 G7 DUAL MOBILITY LINER 40MM D. CAT# 00-6250-065-20 LOT# J6864071 TRILOGY BONE SCR 6.5X20. CAT# 00-8775-028-03 LOT# 2821666 BIOLOX 12/14 CERAMIC FEM HEAD +3.5X28. CAT# 01.00561.219 LOT# 3023671 WAGN CONE PROSTHESIS 125 19. CAT# 110031010 LOT# 64722289 VIVACIT-E DM BEARING 28X40MM. CAT# 31-323230 LOT# 394620 3.2MMX30MM RNGLC+ ACET DRL BIT. CAT# 31-323220 LOT# 232390 3.2MMX20MM RNGLC+ ACET DRL BIT. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL HIP ARTHROPLASTY THAT THE STRAIGHT INSERTER THREADED SHAFT WOULD NOT THREAD ONTO THE HEAD. THERE WAS NO DELAY AND PATIENT WAS NOT AFFECTED. THE RETURNED DEVICE SHOWS THE TIP WAS FRACTURED. 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
    561455 G7 STR INSRTR THREADED SHAFT INSTRUMENT, HIP PBI ZIMMER BIOMET, INC. N/A 432508 00880304551602

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SEE H10.