BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X30MM

    MDR report key: 12725006 · Received October 30, 2021

    Report

    Report Number
    0001825034-2021-03004
    Event Type
    Injury
    Date Received
    October 30, 2021
    Date of Event
    October 6, 2021
    Report Date
    January 27, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: G3; H2; H3; H4; H6.   NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. IMPRESSIONS: LOOSENING OF THE ACETABULAR COMPONENT AND THE FEMORAL COMPONENT IN THE LEFT TOTAL HIP ARTHROPLASTY, WITH FINDINGS ADVANCING OVERTIME POINTS. DIFFERENTIAL CONSIDERATIONS ALSO INCLUDE METALLOSIS AND METAL ON METAL PSEUDOTUMOR, BUT THIS IS NOT FURTHER CHARACTERIZED RADIOGRAPHICALLY. ADDITIONALLY NOTED IS A FRACTURED AND DISPLACED SUPERIOR-MOST SCREW. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE PART: PM157732, LOT: 163570, SPATARO LT TRIFLANGE SZ23 PART: 103532, LOT: 511180, TI LOW PROFILE SCREW 6.5X25MM PART: CP161940, LOT: 795630, TI LOCK-SCR CANCLS 6.5X15MM PART: CP161944, LOT: 821360, TI LOCK-SCR CANCLS 6.5X35MM PART: CP161944, LOT: 821360, TI LOCK-SCR CANCLS 6.5X35MM PART: CP161944, LOT: 821360, TI LOCK-SCR CANCLS 6.5X35MM PART: CP161944, LOT: 858180, TI LOCK-SCR CANCLS 6.5X35MM PART: CP161942, LOT: 569670, TI LOCK-SCR CANCLS 6.5X25MM PART: CP161942, LOT: 158160, TI LOCK-SCR CANCLS 6.5X25MM PART: CP161942, LOT: 627440, TI LOCK-SCR CANCLS 6.5X25MM PART: CP161951, LOT: 272000, TI LOCK-SCR CANCLS 6.5X70MM PART: CP161951, LOT: 978700, TI LOCK-SCR CANCLS 6.5X70MM PART: CP161945, LOT: 785070, TI LOCK-SCR CANCLS 6.5X40MM PART: EP-083650, LOT: 3650075, RLOC-X E1 H/W +3MM 50/36MM 23 PART: 00902603607, LOT: 63016541, FEMORAL HEAD 36 MM DIAMETER MEDIUM 7.0 MM NECK LENGTH (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02973, 0001825034-2021-03003, 0001825034-2021-03005, 0001825034-2021-03008, 0001825034-2021-03009, 0001825034-2021-03010, 0001825034-2021-03011, 0001825034-2021-03012, 0001825034-2021-03014, 0001825034-2021-03015, 0001825034-2021-03016, 0001825034-2021-03017, 0001825034-2021-03018.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION AND SUBSEQUENTLY, THE PATIENT WAS REVISED 5 YEARS LATER DUE TO LOOSENING OF THE CUSTOM TRIFFLANGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623319 TI LOW PROFILE SCREW 6.5X30MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 076020

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10