BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 37.5MM NO 4

    MDR report key: 11192935 · Received January 19, 2021

    Report

    Report Number
    0002249697-2021-00146
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 26, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540153289
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING SIZE/FIT ISSUE INVOLVING A EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THE FOLLOWING: INSPECTION WAS CARRIED OUT AND NOTED THE FOLLOWING: NO DAMAGE IS VISIBLE ON THE STEM. THE GLOBAL SHAPE OF THE STEMS, ESPECIALLY THE END OF THE STEM, HAS BEEN INSPECTED WITHOUT ANY DISCREPANCY. DIMENSIONAL INSPECTION OF THE RETURNED DEVICE NOTED THE FOLLOWING: DURING MANUFACTURING PROCESS, THE END OF THE STEM IS 100% INSPECTED BY GAUGE WIDTH AND THICKNESS LOCATIONS AT THE POLISHING STEP AND THEN 10% INSPECTED DURING FINAL INSPECTION AS REQUESTED ON THE IGS. DIMENSIONAL INSPECTION WAS PERFORMED ON THE PART SENT BACK AS DEFINED IN MANUFACTURING INSTRUCTION. THIS DIMENSIONAL INSPECTION HAS BEEN PERFORMED WITH A GO/NO GO GAUGE. THIS GAUGE IS MAINTAINED ON A TOOL TO GUARANTEE THE LOCATION OF THE STEM DURING THE INSPECTION. THE TOOL AND THE GAUGE ARE REGISTERED IN LMO AND REVIEWED ON DEFINED FREQUENCIES EACH YEAR. THE END OF THE STEM IS COMPLIANT IN BOTH THE WIDTH AND THICKNESS POSITION. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INSPECTION FOUND THAT THE STEM IS COMPLIANT. A REVIEW OF THE EXETER STEM SURGICAL PROTOCOL, NOTED THE FOLLOWING: THE STEM CENTRALIZER IS NOT RETENTIVE AND WHEN PLACED ON THE TIP OF THE STEM IT MAY NEED TO BE HELD IN PLACE AS THE STEM IS TRANSFERRED TO THE FEMUR READY FOR INSERTION. THE CENTRALIZER SHOULD NOT BE FORCED EXCESSIVELY ONTO THE STEM TIP. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    DURING THE PRIMARY TOTAL HIP ARTHROPLASTY, THE FOLLOWING PRODUCT WAS FOUND TO BE DEFECTIVE: 0580-1-374 LOT G7676165. THE DISTAL END OF THE PIN IS THICKER THAN IT SHOULD BE. UNABLE TO PUT ON THE CENTRALIZER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PRIMARY TOTAL HIP ARTHROPLASTY, THE FOLLOWING PRODUCT WAS FOUND TO BE DEFECTIVE: 0580-1-374 LOT G7676165. THE DISTAL END OF THE PIN IS THICKER THAN IT SHOULD BE. UNABLE TO PUT ON THE CENTRALIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90460 EXETER V40 STEM 37.5MM NO 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 0580-1-374 G7676165 04546540153289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other