BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 23495700 · Received November 7, 2025

    Report

    Report Number
    0001825034-2025-03521
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    November 7, 2024
    Report Date
    March 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5; D4; G3; H1; H2; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: D1, D2, D4, D10, G4. D10: ITEM 51-101060 LOT 7564866 TPRLC 133 FP TYPE1 PPS HO 6.0. ITEM 30103606 LOT 66653639 G7 VIT E NEUTRAL LNR 36MM F. ITEM 650-0661 LOT 3200697 DELTA CERAMIC FEM HD 36/0MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO RECURRENT DISLOCATIONS APPROXIMATELY 1 (ONE) MONTH LATER. DURING THE REVISION, THE HEAD WAS NOTED TO BE ANTERIORLY DISLOCATED. THE STEM WAS RETAINED, THE CUP, HEAD AND LINER WERE REVISED WITHOUT COMPLICATIONS. IT WAS NOTED SIGNIFICANT AMOUNT OF DENSE SCAR TISSUE WAS RESECTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594704 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. J7695171 00880304524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O| R UNK STEM AND HEAD.