BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 32MM C

    MDR report key: 21665571 · Received March 21, 2025

    Report

    Report Number
    0001825034-2025-00779
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    February 27, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527010
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D10, G3, G6, H2, H3, H4, H6, H10. D10: 010000701 G7 BONEMASTER LTD ACET SHL 48C 7569976. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED STEM AND HEAD, COVERED WITH BIO DEBRIS. THE STEM COMPONENT IS SEEN WITH LARGE TISSUE MASS ON THE POROUS COATING, WITH SOME AREAS OF THE POROUS COATING WITH DAMAGE. NO OTHER OBSERVATIONS CAN BE MADE FOR THE STEM AND HEAD USING THE IMAGE ALONE. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS OF THE RIGHT HIP DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION OF THE ACETABULAR CUP. MILD RADIOLUCENCY OF THE CEMENT HARDWARE INTERFACE. FEMORAL COMPONENT ALSO DEMONSTRATES MILD RADIOLUCENCY OF THE CEMENT HARDWARE INTERFACE. RIGHT TOTAL HIP ARTHROPLASTY WITH POSSIBLE EVIDENCE OF EARLY LOOSENING OF THE ACETABULAR AND FEMORAL COMPONENTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE PROVIDED IMAGE AND MMI, THE COMPLAINT IS CONFIRMED. 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

    (B)(4). D10: 163667 32MM MOD HEAD COCR -6MM NECK 65875036. 51-117090 TPRLC 133 MP TYPE1 BM HO 9.0 66438359. G2: FOREIGN: AUSTRALIA . CUSTOMER HAS INDICATED THAT THE PRODUCT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE. THE PATIENT DID WELL FOR THE FIRST FEW MONTH¿S POST OPERATIONS, HOWEVER, THE PATIENT RECENTLY SUFFERED RECURRENT DISLOCATIONS. NO TRAUMATIC EVENT PROCEEDED OR RESULTED FROM ANY OF THESE DISLOCATIONS. A CT WAS ORDERED, AND THE FEMORAL STEM WAS DEEMED TO BE IN AN INSUFFICIENT DEGREE OF ANTEVERSION. THE STEM WAS CHANGED TO A MODULAR ARCOS TO CORRECT THE ANTEVERSION AND THE HIGH WALL LINER WAS EXCHANGED FOR A DUAL MOBILITY. THE G7 IN SITU WAS RETAINED. NO SIGNS OF INFECTION. NO FRACTURES PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545733 G7 HI-WALL E1 LINER 32MM C PROSTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 7240687 00880304527010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R SEE H11 NARRATIVE| SEE H11 NARRATIVE