BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING

    MDR report key: 22893048 · Received August 26, 2025

    Report

    Report Number
    0001822565-2025-03098
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 11, 2023
    Report Date
    October 31, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119819
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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: D4; G3; H2; H4; H6; H10. PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. REPORTED EVENT IS NOT RELATED TO DEVICE THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. FURTHERMORE, BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE (THE FLUID FILLED SAC THAT CUSHIONS THE JOINT) AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE TO THE BURSAE. BURSITIS IS A VERY COMMON CONDITION THAT CAN IMPACT ANY OF THE JOINTS AND CAN LAST FOR A SHORT DURATION OR YEARS. SYMPTOMS THE PATIENT CAN EXPERIENCE INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. CONSERVATIVE TREATMENT CONSISTS OF OVER THE COUNTER (OTC) MEDICATIONS PAIN RELIEVERS AND ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND APPLYING PRESSURE WRAPS. IF CONSERVATIVE TREATMENTS FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOP BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION FOR TREATMENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER. ITEM: 00786401120. LOT: 64960534. 32MM I.D. SIZE D HIGH WALL LINER. ITEM: 20123204. LOT: 64580197. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH. ITEM: 00625006535. LOT: J7259867. G7 OSSEOTI MULTIHOLE 50MM D. ITEM: 110010263. LOT: 65210707. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14. ITEM: 00877503202. LOT: 3103842. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONGOING TROCHANTERIC BURSITIS REQUIRING CORTISONE INJECTIONS AT 11, 16, AND 19 MONTHS POSTOP. NO COMPLICATIONS CONCERNING THE IMPLANTS HAVE BEEN IDENTIFIED ON X-RAY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630683 BONE SCREW SELF-TAPPING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. J7278087 00889024119819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11