BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 4

    MDR report key: 11192107 · Received January 19, 2021

    Report

    Report Number
    0002249697-2021-00140
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 18, 2020
    Report Date
    April 20, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540153333
    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 BY LISI MEDICAL ORTHOPAEDICS 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 GAGE 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 GAGE. THIS GAGE IS MAINTAINED ON A TOOL TO GUARANTEE THE LOCATION OF THE STEM DURING THE INSPECTION. THE TOOL AND THE GAGE 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 HAS BEEN 1 OTHER COMPLAINT FOR THE LOT REFERENCED. THE COMPLAINT IS PART OF THE SAME OVERALL PI AND WAS FOR THE SAME PATIENT DURING THE SAME SURGERY WITH THE SAME SURGEON. CONCLUSIONS: THE INSPECTION BY LISI MEDICAL ORTHOPAEDICS FOUND THAT THE STEM IS COMPLIANT. A REVIEW OF THE EXETER STEM SURGICAL PROTOCOL, EXETER-SP-6EN REV-4 17192 DLS 06/2018, NOTED THE FOLLOWING: THE STEM CENTRALISER 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 CENTRALISER 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, A DEFECT IN PRODUCTS 0580-1-444 LOT G7986847 (TWO IDENTICAL PRODUCTS) WAS DETECTED. 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.

    Description of Event or Problem · 1

    DURING THE PRIMARY TOTAL HIP ARTHROPLASTY, A DEFECT IN PRODUCTS 0580-1-444 AND LOT G7986847 TWO IDENTICAL PRODUCTS) WAS DETECTED. 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
    93981 EXETER V40 STEM 44MM NO 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 0580-1-444 G7986847 04546540153333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other