BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG

    MDR report key: 22162158 · Received June 7, 2025

    Report

    Report Number
    0008031020-2025-00948
    Event Type
    Injury
    Date Received
    June 7, 2025
    Date of Event
    May 13, 2025
    Report Date
    September 25, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K213328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF MIGRATED LAG SCREW COULD BE CONFIRMED, SINCE BASED ON X-RAY IMAGES PROVIDED THE REPORTED LAG SCREW MEDIALIZATION COULD BE VERIFIED. FURTHERMORE, THIS IS CONSEQUENTLY RESULTING IN HARDWARE REMOVAL AS CONFIRMED WITHIN EVENT DESCRIPTION ¿WE HAVE THE HARDWARE IN HAND UNOPENED FROM THE SURGEON THAT REMOVED, WHICH HAS TO BE CLASSIFIED AS ADVERSE IMPACT TO PATIENT ¿ POSTOPERATIVELY. CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS AND POTENTIAL ADVERSE EFFECTS ARE POINTED OUT IN THE IFU: THE OPERATION TECHNIQUE[S] ARE PRESENTED IN THE APPROPRIATE OPERATION TECHNIQUE. THE RMF CONSIDERS THAT A REVISION SURGERY DUE TO CUT OUT OR MEDIALIZATION IS A TYPICAL COMPLICATION OF PROXIMAL FEMORAL NAILING. THIS HARM DOES NOT PRIMLY DEPEND ON THE IMPLANT. IT IS MOSTLY CAUSED BY THE KIND OF FRACTURE, PATIENT'S GENERAL CONDITION, AND PRIMLY THE RESPECTIVE SURGICAL TECHNIQUE. THE BASICS OF THE GAMMA-SYSTEM ARE THE INTERACTION OF NAIL SET, INCLUDING A SET SCREW AND IN COMBINATION WITH LAG SCREW IN THE PROXIMAL AREA. THE INTENTION IS TO ALLOW THE FRACTURE SITE TO SUBSIDE [IF THE FRACTURE GAP IS TOO BIG] IN ORDER TO SUPPORT BONE UNION. THIS REQUIRES MOTION IN A RELATIVE RIGID CONSTRUCTION AND IS SOLVED BY LATERALIZATION OF THE LAG SCREW. THE SET SCREW ¿ AS PART OF THE NAIL KIT - IS DESIGNED TO FIT INTO ONE OF THE GROOVES OF THE SHAFT OF THE LAG SCREW WITH ASCENDING SHAPES AT BOTH MEDIAL AND LATERAL. THIS PREVENTS BOTH ROTATION AND COMPLETE MIGRATION OF THE LAG SCREW BUT ALLOWS SLIDING IN A LIMITED AND DEFINED RANGE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE FILE WILL BE CLOSED FORMALLY IN ACCORDANCE TO OUR PROCEDURES. IN CASE THE ITEM AND OR SUBSTANTIVE INFORMATION WILL BECOME AVAILABLE IN FUTURE THE FILE WILL BE REVIEWED AND REOPENED.

    Description of Event or Problem · 0

    AS REPORTED: "MY FATHER RECENTLY HAD A BROKERS FEMUR. UPPER FEMUR HAD THE GAMMA 4 HIP NAILING SYSTEM INSTALLED HERE IN (B)(6). AFTER INSTALLATION IT SLOWLY STARTED JACKHAMMERING THROUGH HIS UPPER FEMUR, HIP SOCKET AND PELVIS AND EVENTUALLY THE SCREW BROKE THROUGH THE PELVIS AND WAS FREE FLOWING IN HIS PELVIS AREA. THEY HAD A MAJOR SURGERY TO REMOVE THE SCREW AND AS A RESULT HAD A FULL HIP REPLACEMENT. I'M CALLING YOU TO JUST TALK TO SOMEBODY ABOUT THE FAILED HIP GAMMA 4 HIP FRACTURE. WE BELIEVE IT WAS DOCTOR EYRE. WE HAVE THE HARDWARE IN HAND UNOPENED FROM THE SURGEON THAT REMOVED IT AND I'D LIKE TO DISCUSS WITH SOMEBODY. WE BELIEVE THE SET SCREW WAS NOT PROPERLY ENGAGED TO ONE OF THE THREE GROOVES BECAUSE THERE'S NO INDICATION OR MARKS WHATSOEVER IN ANY OF THE THREE GROOVES. THERE ARE MARKS ALL OVER THE OUTSIDE OF THE SCREW, BUT ONCE AGAIN, THE FAILED FEMORAL HIP GAMMA 4 HIP FRACTURE NAILING SYSTEM FAILED, AND MY DAD'S, WHO'S 91".

    Description of Event or Problem · 0

    AS REPORTED: "MY FATHER RECENTLY HAD A BROKERS FEMUR. UPPER FEMUR HAD THE GAMMA 4 HIP NAILING SYSTEM INSTALLED HERE IN (B)(6). AFTER INSTALLATION IT SLOWLY STARTED JACKHAMMERING THROUGH HIS UPPER FEMUR, HIP SOCKET AND PELVIS AND EVENTUALLY THE SCREW BROKE THROUGH THE PELVIS AND WAS FREE FLOWING IN HIS PELVIS AREA. THEY HAD A MAJOR SURGERY TO REMOVE THE SCREW AND AS A RESULT HAD A FULL HIP REPLACEMENT. I'M CALLING YOU TO JUST TALK TO SOMEBODY ABOUT THE FAILED HIP GAMMA 4 HIP FRACTURE. WE BELIEVE IT WAS DOCTOR EYRE. WE HAVE THE HARDWARE IN HAND UNOPENED FROM THE SURGEON THAT REMOVED IT AND I'D LIKE TO DISCUSS WITH SOMEBODY. WE BELIEVE THE SET SCREW WAS NOT PROPERLY ENGAGED TO ONE OF THE THREE GROOVES BECAUSE THERE'S NO INDICATION OR MARKS WHATSOEVER IN ANY OF THE THREE GROOVES. THERE ARE MARKS ALL OVER THE OUTSIDE OF THE SCREW, BUT ONCE AGAIN, THE FAILED FEMORAL HIP GAMMA 4 HIP FRACTURE NAILING SYSTEM FAILED, AND MY DAD'S, WHO'S (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492732 GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH K18D18F

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Required Intervention