BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA 3 U-BLADE LAG SCREW

    MDR report key: 12040175 · Received June 22, 2021

    Report

    Report Number
    0009610622-2021-00566
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    December 10, 2019
    Report Date
    July 22, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED CUT-OUT AND NON UNION MENTIONED IN THE ARTICLE COULD BE CONFIRMED THROUGH THE X-RAY AND ADDITIONAL INFORMATION AVAILABLE IN THE ARTICLE. THE AVAILABLE INFORMATION AND THE X-RAYS WERE PRESENTED TO AN INDEPENDENT HEALTHCARE PROFESSIONAL FOR A CLINICAL OPINION. STRICTLY BASED ON THE AVAILABLE INFORMATION THE HCP OPINED THAT THE TREATMENT OF THE GIVEN FRACTURE WITH THE IMPLANT USED IN THIS SURGERY IS QUESTIONABLE. THE FRACTURE PATTERN IS EXACTLY WHERE THE LAG SCREW NEEDS TO ENTER THE LATERAL ASPECT OF THE FEMUR. THERE IS NO STABILITY WHATSOEVER FOR THE LAG SCREW ON THIS SIDE. FURTHER, IT WAS ALSO UNCLEAR WHETHER THE PATIENT HAD OSTEOPOROTIC BONES OR NOT BUT GIVEN THE AGE OF THE PATIENT IT IS LIKELY. HENCE, IT IS POSSIBLE THAT THE MEDIAL ASPECT OF THE LAG SCREW MAY NOT BE SUPPORTED IN THE FEMORAL HEAD. HENCE THE LACK OF STABILITY ON BOTH THE SIDES MAY HAVE LED TO THE DELAYED HEALING AND CUT OUT. STRICTLY BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE ISSUE IS DEEMED TO BE A COMBINATION OF BOTH USER AND PATIENT RELATED FACTORS, BUT PREDOMINANTLY PATIENT RELATED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF ORTHOPAEDIC SURGERY, GANGNAM SACRED HEART HOSPITAL, IN SOUTH KOREA. THE TITLE OF THIS REPORT IS ¿GAMMA 3 U-BLADE LAG SCREWS IN PATIENTS WITH TROCHANTERIC FEMUR FRACTURES: ARE ROTATION CONTROL LAG SCREWS BETTER THAN OTHERS?¿ PUBLISHED ON DECEMBER 16, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S13018-019-1427-Z. THIS REPORT INCLUDES RESEARCH DONE ON 185 PATIENTS BETWEEN THE PERIOD JANUARY 2011 AND JUNE 2016. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES NONUNION DUE TO SCREW CUT-OUT FOR WHICH REVISION SURGERY WAS PERFORMED BY HEMIARTHROPLASTY. THE REPORT STATES AN 83-YEAR-OLD WOMAN SUFFERED FROM A FALL FROM A HEIGHT AT HOME; THE FRACTURE TYPE WAS REVERSE OBLIQUE (A32) [¿]. THE FRAGMENT WAS REDUCED USING A GAMMA 3 RC SCREW [¿]. THE LAG SCREW DEMONSTRATED CUT-OUT OF THE HEAD 3 MONTHS POSTOPERATIVELY [¿] WHICH WAS CONVERTED VIA HEMIARTHROPLASTY.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF ORTHOPAEDIC SURGERY, (B)(6) HOSPITAL, IN (B)(6). THE TITLE OF THIS REPORT IS ¿GAMMA 3 U-BLADE LAG SCREWS IN PATIENTS WITH TROCHANTERIC FEMUR FRACTURES: ARE ROTATION CONTROL LAG SCREWS BETTER THAN OTHERS?¿ PUBLISHED ON DECEMBER 16, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S13018-019-1427-Z. THIS REPORT INCLUDES RESEARCH DONE ON 185 PATIENTS BETWEEN THE PERIOD JANUARY 2011 AND JUNE 2016. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES NONUNION DUE TO SCREW CUT-OUT FOR WHICH REVISION SURGERY WAS PERFORMED BY HEMIARTHROPLASTY. THE REPORT STATES AN (B)(6) YEAR-OLD WOMAN SUFFERED FROM A FALL FROM A HEIGHT AT HOME; THE FRACTURE TYPE WAS REVERSE OBLIQUE (A32) [¿]. THE FRAGMENT WAS REDUCED USING A GAMMA 3 RC SCREW [¿]. THE LAG SCREW DEMONSTRATED CUT-OUT OF THE HEAD 3 MONTHS POSTOPERATIVELY [¿] WHICH WAS CONVERTED VIA HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940832 UNKNOWN GAMMA 3 U-BLADE LAG SCREW IMPLANT HWC STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R