BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132 SIZE 5 SECUR-FIT ADVANCED STEM

    MDR report key: 8523464 · Received April 17, 2019

    Report

    Report Number
    0002249697-2019-01646
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 20, 2019
    Report Date
    June 17, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327021264
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING A SIZE/FIT ISSUE AND INTRAOPERATIVE FRACTURE INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THE FOLLOWING: NOTHING REMARKABLE TO REPORT. DIMENSIONAL INSPECTION ON THE RETURNED DEVICE WAS NOT PERFORMED AS THE DEVICE WAS PROCESSED THROUGH CP TITANIUM COATING PROCESS BY APS-MATERIALS, INC. AND THERE ARE NO DIMENSIONAL SPECIFICATIONS OF THE POST-COATING DEVICES. 100% DIMENSIONAL INSPECTION AND COATING THICKNESS INSPECTION WAS COMPLETED ON THE DEVICES OF REPORTED LOT. REFER TO PRODUCT HISTORY REVIEW SECTION FOR DETAILS. FUNCTIONAL INSPECTION WAS NOT PERFORMED BECAUSE THE EVENT DOES NOT RELATE TO DEVICE FUNCTION. MATERIAL ANALYSIS IS NOT PERFORMED AS THIS IS NOT RELATED TO MATERIAL INTEGRITY. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE WERE 100% DIMENSIONAL INSPECTION CONDUCTED PRIOR TO THE CP TITANIUM COATING PROCESS AND ALL 5 DEVICES MET THE DIMENSIONAL INSPECTION. COATING THICKNESS INSPECTION OF THE 5 DEVICES WAS COMPLETED AND ALL MET THE SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: BASED ON THE DEVICE HISTORY REVIEW, THERE WERE 100% DIMENSIONAL INSPECTION CONDUCTED PRIOR TO THE CP TITANIUM COATING PROCESS AND ALL 5 DEVICES MET THE DIMENSIONAL INSPECTION. COATING THICKNESS INSPECTION OF THE 5 DEVICES WAS COMPLETED AND ALL MET THE SPECIFICATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    SALE REP REPORTED, DURING A HEMI ARTHROPLASTY THE PROSTHESIS RECEDED FURTHER THAN INTENDED. SURGEON STATED THE PROSTHESIS APPEARED TO BE SMALLER THAN THE SIZE 5. SURGEON PROCEEDED WITH A SIZE 6 PROSTHESIS AND COMPLETED SURGERY SUCCESSFULLY. IT WAS NOTED BY THE REP THAT THERE WAS A FRACTURE ON THE BONE AND SUSPECTS THAT THE STEM MOVED DUE TO THE FRACTURE. THERE WAS APPROXIMATELY A 5 MINUTE SURGICAL DELAY.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SALE REP REPORTED, DURING A HEMI ARTHROPLASTY THE PROSTHESIS RECEDED FURTHER THAN INTENDED. SURGEON STATED THE PROSTHESIS APPEARED TO BE SMALLER THAN THE SIZE 5. SURGEON PROCEEDED WITH A SIZE 6 PROSTHESIS AND COMPLETED SURGERY SUCCESSFULLY. IT WAS NOTED BY THE REP THAT THERE WAS A FRACTURE ON THE BONE AND SUSPECTS THAT THE STEM MOVED DUE TO THE FRACTURE. THERE WAS APPROXIMATELY A 5 MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315974 132 SIZE 5 SECUR-FIT ADVANCED STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH X91PX4 07613327021264

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R