BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 56F

    MDR report key: 18876646 · Received March 11, 2024

    Report

    Report Number
    0001825034-2024-00680
    Event Type
    Injury
    Date Received
    March 11, 2024
    Report Date
    March 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524248
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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) 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. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THE REPORTED EVENT (BURSITIS) IS A PROCEDURE RELATED COMPLICATION AND NOT DEVICE RELATED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED. 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: CAT# 20103606 LOT# 65509444 LINER G7, LONGEVITY. CAT# 6500662 LOT# 3062881 HEAD BIOLOX DELTA CERAMIC 36. +3. CAT# 51103140 LOT# 6977477 STEM TAPERLOC COMPLETE PPS, 14 X 148. PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2024-00681.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT BEGAN TO EXPERIENCE RIGHT LATERAL PAIN. THE PAIN WAS THOUGHT TO BE ATTRIBUTED TO TROCHANTER BURSITIS AND IT BAND IRRITATION. THE PATIENT WAS INSTRUCTED TO USE ICING TECHNIQUES, TOPICAL CREAMS, AND WAS PRESCRIBED MELOXICAM AND PHYSICAL THERAPY. AT THE ONE-YEAR POST-OPERATIVE, THE PATIENT IS PROGRESSING WITHOUT COMPLICATIONS, AND ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969031 G7 PPS LTD ACET SHELL 56F PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7067194 00880304524248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other