BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 23475494 · Received November 5, 2025

    Report

    Report Number
    0001825034-2025-03465
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304521391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT # 51-100050 AND 510(K) K103755. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT HAD AN INITIAL LEFT THA. NO COMPLICATIONS WERE NOTED IN THE OPERATIVE NOTES PROVIDED FROM THE INITIAL PROCEDURE, AND REPORTED GOOD STABILITY AND GOOD LEG LENGTH POST OP. THE PATIENT HAS A REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. NO OPERATIVE NOTES WERE PROVIDED FOR THE REVISION. AN X-RAY IMAGE WAS PROVIDED. REVIEW IDENTIFIED THE FOLLOWING: AP AND FROG-LEG LATERAL VIEWS OF THE LEFT HIP SHOW PRESENCE OF TOTAL HIP ARTHROPLASTY. ANCHORS PROJECT OVER THE GREATER TROCHANTER AND PROXIMAL LATERAL FEMORAL SHAFT. POSITION AND ALIGNMENT OF HIP ARTHROPLASTY COMPONENTS APPEARS STANDARD. NO IMPLANT LOOSENING, IMPLANT FRACTURE OR PERIPROSTHETIC BONE FRACTURE IS IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1157 LOT# 3219195 DELTA CER FEM HD 28/+3MM T1. G2: FOREIGN ¿ AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE. HAD AND STEM WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606904 TAPERLOC COMPLETE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7178702 00880304521391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R