BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    MDR report key: 16918476 · Received May 12, 2023

    Report

    Report Number
    0001825034-2023-00988
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    June 22, 2020
    Report Date
    September 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304544185
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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/CORRECTED UPDATED: D6B: EXPLANT DATE PROVIDED IN ERROR .

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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) MEDICATION 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 FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 193109 ECHO B-MTRC MP FP HO 9 LOT NUMBER: 089870 010000856 G7 NEUTRAL E1 LINER 36MM D LOT NUMBER: 6383738 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00990, 0001825034 - 2023 - 00989. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR BURSITIS AND TREATED WITH FORMAL PHYSICAL THERAPY AND OVER THE COUNTER TOPICAL CREAM FOR ONGOING PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE 2 MONTHS POST IMPLANTATION DUE TO AN INFECTION. THE ACETABULAR LINER, HEAD AND SLEEVE WERE EXCHANGED, AND THE PATIENT WAS PLACED ON AN ANTIBIOTIC REGIMEN. 6 DAYS POST OPERATIVELY, THE PATIENT HAD CELLULITIS, PAIN, ERYTHEMA AND SWELLING AND WAS INSTRUCTED TO CONTINUE ANTIBIOTIC REGIMENT. THE INFECTION RESOLVED 15 MONTHS LATER. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE, HOWEVER PER DETAILS AVAILABLE CUP AND STEM REMAIN IMPLANTED WITH NO ADDITIONAL DEVICE RELATED ALLEGATIONS KNOWN. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356208 G7 OSSEOTI 3 HOLE SHELL 50MM D PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 6378467 00880304544185

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H PLEASE SEE H10.