BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM I.D. SIZE D HIGH WALL LINER

    MDR report key: 22893139 · Received August 26, 2025

    Report

    Report Number
    0001822565-2025-03100
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    October 4, 2023
    Report Date
    January 2, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520479
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ZB 12/14 COCR HD 36MM X +0 ITEM: 802203602 LOT: 3110068. G7 PPS LTD ACET SHELL 50D ITEM: 010000662 LOT: 7464476. AVENIR STANDARD, CEMENTED SZ 2 ITEM: 0106010202 LOT: 3080557. G2: DENMARK. 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; H4; H6; H10. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND THE FOLLOWING: 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. PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. 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 RECEIVED A MEDICAL BLOCKADE APPROXIMATELY THREE AND A HALF MONTHS POST IMPLANTATION DUE TO TROCHANTER BURSITIS, WHICH WAS POSSIBLY CAUSED BY A FALL. THE OUTCOME OF THE COMPLICATION WAS NOTED AS TOLERATED. 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
    2722754 36MM I.D. SIZE D HIGH WALL LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 65612905 00889024520479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention