BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION STEM 15/225

    MDR report key: 22108066 · Received May 29, 2025

    Report

    Report Number
    0009613350-2025-00386
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    UDI-DI
    00889024485198
    PMA / PMN Number
    K871347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. FREEDOM STD FACE LINER SZ 24 ITEM# 11-107323 LOT# 998600. CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +6 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS ITEM# 802403605 LOT# 3103183. VERSYS HERITAGE 16X145MM ST ITEM# 00-7857-016-00 LOT# 66430076. VH PROX CNTRLZR SLEEVE 16 ITEM# 00-7858-016-57 LOT# 65803836. DISTAL CENTRALIZER 13MM ITEM# 00-7859-013-00 LOT# 65346636. RINGLOC+ REPLACEMENT RING SZ24 ITEM# 106024 LOT# 721900. BIOLOX DELTA HEAD 12/14 36X0 ITEM# 00-8775-036-02 LOT# 2968780. CABLE READY GTR COCR CABLE ITEM# 00-2232-004-18 LOT# 64277340. CABLE READY GTR COCR CABLE ITEM# 00-2232-004-18 LOT# 64324841. CABLE READY GTR COCR CABLE ITEM# 00-2232-004-18 LOT# 64245449. EPOLY RLC 36MM 10DEG SZ24 SZ24 ITEM# EP-105894 LOT# 159620. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, B7, G3, G6, E1, H2, H6, H11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. TWO AP X-RAYS (OF WHICH ONE WITH INCOMPLETE OVERVIEW OF THE STEM) AND A LATERAL ONE WERE PROVIDED AND REVIEWED. ALL THE RADIOGRAPHS ARE UNDATED BUT ALLEGEDLY TAKEN BEFORE SECOND REVISION SURGERY. BASED ON THE PROVIDED IMAGES, A FRACTURE OF THE STEM IN THE DISTAL AREA CAN BE CONFIRMED. SCLEROTIC LINES AND A GAP BETWEEN THE DEVICE AND THE BONE ARE VISIBLE IN ALL PROVIDED IMAGES, ESPECIALLY IN THE LATERAL VIEW. HOWEVER, DUE TO THE LACK OF OTHER RADIOGRAPHS TAKEN ON PREVIOUS TIME POINTS, IT CANNOT BE ESTABLISHED IF THIS WAS ALREADY PRESENT AT THE MOMENT OF IMPLANTATION, OR DEVELOPED DURING THE TIME IN VIVO. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED, BUT A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP SURGERY, SUBSEQUENTLY UNDERWENT A REVISION DUE TO UNKNOWN REASON AND AFTER THIS, THE PATIENT WAS REVISED AGAIN, APPROXIMATELY 6 YEARS LATER, DUE TO ASEPTICALLY LOOSE AND BROKEN FEMORAL COMPONENT. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2016 WITH AN UNKNOWN PRODUCT. AFTER THIS, HAD A 1ST REVISION DUE TO LOOSENING APPROXIMATELY 3 YEARS POST-IMPLANTATION. SUBSEQUENTLY, APPROXIMATELY 6 YEARS LATER, UNDERWENT A 2ND REVISION DUE TO LOOSENING AND IMPLANT FRACTURE FROM FALLING. DURING THE PROCEDURE THE STEM WAS GROSSLY LOOSE WITH THE DISTAL PORTION OF THE STEM WELL FIXED. SHELL WAS WELL FIXED AND REMAINED IMPLANTED. THE STEM, HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709131 WAGNER SL REVISION STEM 15/225 PROSTHESIS, HIP JDI ZIMMER GMBH 2912687 00889024485198

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H SEE H11 NARRATIVE.