BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM

    MDR report key: 22890395 · Received August 25, 2025

    Report

    Report Number
    0001822565-2025-03090
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    October 25, 2024
    Report Date
    January 12, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119819
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: G7 OSSEOTI MULTIHOLE 54MM F ITEM: 110010265 LOT: 65320756. BONE SCR 6.5X35 SELF-TAP 00625006535 J7273829. BIOLOX® DELTA, CERAMIC FEMORAL HEAD 00877503602 3103706 FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER 00786401320 62868563. THE CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD AN INITIAL RIGHT THA IN (B)(6) 2022. AT 6 WEEKS POSTOP, PATIENT REPORTED MILD PAIN, LIMP AND DIFFICULTIES. FOLLOW UPS FOR 1 YEAR AND 2-YEAR POST OP, FOUND NO PAIN AND NO COMPLICATIONS RADIOGRAPHICALLY. AT 2 YEARS POST OP, IT WAS IDENTIFIED PSOAS TENDINITIS AND WAS REFERRED FOR TENDON INJECTION UNDER FLOURO. THE PATIENT REPORTS INTERMITTENT SNAPPING IN THE HIP, TENDERNESS IN HIP FLEXOR MUSCLES AND PAIN WITH FLEXION. X-RAYS SHOW NO LOOSENING, WEAR OR LYSIS. CLINICAL NOTES SUGGEST PATIENT HAS ILIOPSOAS TENDINITIS ON THE RIGHT WHICH OCCURS WHEN THE HIP IS PLACED IN EXTREME ROTATIONAL POSITIONS. THIS MAY BE RELATED TO IMPINGEMENT AGAINST THE ACETABULAR CUP OR LINER. IT WAS DISCUSSED THAT HE SHOULD AVOID EXTREME HIP POSITIONS. THE SURGEON WILL ARRANGE A RIGHT ILIOPSOAS TENDON INJECTION UNDER FLUOROSCOPIC GUIDANCE. 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. 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 TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SNAPPING IN THE HIP APPROXIMATELY TWO YEARS POST-IMPLANTATION. IT WAS CONFIRMED THAT THE PATIENT HAD ILIOPSOAS TENDINITIS CAUSED BY IMPINGEMENT. PATIENT WAS REFERRED FOR AN INJECTION UNDER FLUOROSCOPY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484867 BONE SCREW SELF-TAPPING 6.5 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. J7290883 00889024119819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11