BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 50D

    MDR report key: 22884490 · Received August 25, 2025

    Report

    Report Number
    0001825034-2025-02672
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    October 4, 2023
    Report Date
    January 2, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524217
    PMA / PMN Number
    K121874
    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: G7 VIT E HIGH WALL LNR 36MM D. ITEM: 30123604. LOT: 65612905. ZB 12/14 COCR HD 36MM X +0. ITEM: 802203602. LOT: 3110068. 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: G3; H2; H6. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. THIS DEVICE IS USED FOR TREATMENT. THIS IS A LIMITED INVESTIGATION, AS PER (B)(4), A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. ADDITIONALLY, PART AND LOT/SERIAL IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND A COMPLAINT HISTORY REVIEW, NEITHER WERE PROVIDED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. PRODUCT WILL NOT BE EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED 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

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391104 G7 PPS LTD ACET SHELL 50D PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 7464476 00880304524217

    Patients

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