BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/C II CONSTRAINED LINER SZ 24

    MDR report key: 18141646 · Received November 15, 2023

    Report

    Report Number
    0001825034-2023-02650
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 16, 2023
    Report Date
    March 13, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00880304203396
    PMA / PMN Number
    K021728
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: STRYKER C-TAPER(COMPETITOR) CAT# PM0003221 LOT# 012270 MITCHELL RIGHT TRIFLANGE SZ 24, CAT# CP161944 LOT# 514550 TI LOCK-SCR CANCLS 6.5X35MM, CAT# CP161947 LOT# 756770 TI LOCK-SCR CANCLS 6.5X50MM, CAT# CP161951 LOT# 136710 TI LOCK-SCR CANCLS 6.5X70MM, CAT# CP161942 LOT# 995540 TI LOCK-SCR CANCLS 6.5X25MM, CAT# CP161943 LOT# 481450 TI LOCK-SCR CANCLS 6.5X30MM, CAT# CP161944 LOT# 295900 TI LOCK-SCR CANCLS 6.5X35MM, CAT# CP161943 LOT# 287460 TI LOCK-SCR CANCLS 6.5X30MM, CAT# CP161943 LOT# 262410 TI LOCK-SCR CANCLS 6.5X30MM, CAT# CP161942 LOT# 259660 TI LOCK-SCR CANCLS 6.5X25MM, CAT# CP161942 LOT# 259660 TI LOCK-SCR CANCLS 6.5X25MM, CAT# CP161942 LOT# 259660 TI LOCK-SCR CANCLS 6.5X25MM, CAT# CP161942 LOT# 258710 TI LOCK-SCR CANCLS 6.5X25MM, CAT# CP161942 LOT# 258710 TI LOCK-SCR CANCLS 6.5X25MM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A RIGHT THA. THREE YEARS LATER, THE PATIENT PRESENTED WITH PAIN, SWELLING, AND DIFFICULTY AMBULATING. THE COMPETITOR STEM WAS IMPINGING ON THE POLY. 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 DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT THEIR FOURTH REVISION APPROXIMATELY 25 YEARS LATER DUE TO INCREASED PAIN, SWELLING, AND DIFFICULTY AMBULATING. IMAGING SHOWED A LARGE COMPLEX FLUID COLLECTION SURROUNDING THE STEM AND NECK. DURING THE REVISION, THE FRIABLE TISSUE AND CHRONIC ADVERSE LOCAL TISSUE REACTION WAS DEBULKED FROM THE JOINT. POSTERIOR IMPINGEMENT OF THE NECK ON THE POLY WAS NOTED, BUT THE LOCKING RING WAS INTACT AND NOT DAMAGED. NO CORROSION WAS IDENTIFIED ON THE IMPLANTS, AND THE TRIFLANGE CAGE REMAINED STABLE. A NEW HEAD AND LINER WERE PLACED, AND NONABSORBABLE SUTURES WERE USED TO CLOSE THE DEAD SPACE OF THE JOINT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321892 R/C II CONSTRAINED LINER SZ 24 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 597540 00880304203396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE.