BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM -3.5MM 12/14 UNIVERSAL TRIAL HEAD

    MDR report key: 17457761 · Received August 4, 2023

    Report

    Report Number
    0001822565-2023-02082
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    May 11, 2023
    Report Date
    December 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 574202060 FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 6 3137541. 010000663 G7 PPS LTD ACET SHELL 52E 7450970. 00625006525 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH J7458211. 30103605 36MM I.D. SIZE E NEUTRAL LINER 65875351. 00877503601 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14 3144443. 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 MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PROPOSED COMPONENT CODE- MECHANICAL (G04)- HEAD. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE EXPLANTED FRAGMENT OF THE BROKEN TRIAL PIECE AND IS COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, AS THE LOT NUMBER IS UNKNOWN, AN ADDITIONAL REVIEW COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR FOR OVERTIGHTENING THE JOINT LEADING TO BREAKING THE TRIAL. THE PIECE WAS RETAINED AND LEAD TO THE DISLOCATION. PER THE INSTRUMENT/PROVISIONAL USE, CARE, AND STERILIZATION IFU, IT'S NOTED NOT TO SUBJECT INSTRUMENTS TO HIGH LOADS AND/OR IMPACT AS BREAKAGE CAN OCCUR, WHICH CAN LEAD TO POTENTIAL ADVERSE EFFECTS ON USER(S) OR PATIENT. MISUSE REDUCES USEFUL LIFE AND/OR INCREASES INJURY RISK. THIS COMPLAINT WAS CONFIRMED BASED ON PROVIDED PICTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON HAD A HARD TIME DISLOCATING THE TRIAL AS THE PATIENT¿S LEG LENGTHS WERE TOO LONG. THE SURGEON WAS UNABLE TO DISLOCATE THE PATIENT FOR AN ANTERIOR APPROACH AND PURPOSELY SHATTERED THE TRIAL HEAD BREAKING THE HEAD INTO PIECES. A BROKEN PIECE REMAINED IN THE PATIENT¿S BODY. THE PATIENT DISLOCATED DUE TO THE BROKEN PIECE AND NEEDED ADDITIONAL SURGERY.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951280 36MM -3.5MM 12/14 UNIVERSAL TRIAL HEAD HIPS, INSTRUMENTS HWT ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other