BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 50MM NO 1

    MDR report key: 8583615 · Received May 6, 2019

    Report

    Report Number
    0002249697-2019-01855
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 2, 2019
    Report Date
    August 13, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    04546540153364
    PMA / PMN Number
    K173499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DAMAGE INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED DEVICE. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED BY LISI MEDICAL WHICH NOTED THE FOLLOWING: THE SPIGOT PROTECTOR IS BENT AT THE TOP OF ONE OF THE LEG: DURING THE PACKAGING STEP, AN ASSEMBLY BETWEEN THE SPIGOT AND THE STEM IS DONE. A 100% VISUAL INSPECTION IS PERFORMED. THIS ASSEMBLY IS REALIZED MANUALLY, WITHOUT ANY TOOL. SO, THIS IS NOT POSSIBLE TO GENERATE A BEND AS SHOWN ABOVE IN LMO¿S MANUFACTURING PROCESS. MOREOVER, THE PICTURES SHOW THAT THE SPIGOT HAS BEEN DAMAGED (KNOCKS). THESE DAMAGES ARE TYPICAL AS A MISUSE WITH THE INSTRUMENT. THIS MISUSE LEAD TO A BENT OF THE LEG AND COULD GENERATE A BREAK OF THE LEG. -CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED BY LISI MEDICAL WHICH NOTED THE FOLLOWING: THE SPIGOT PROTECTOR IS BENT AT THE TOP OF ONE OF THE LEG: DURING THE PACKAGING STEP, AN ASSEMBLY BETWEEN THE SPIGOT AND THE STEM IS DONE. A 100% VISUAL INSPECTION IS PERFORMED. THIS ASSEMBLY IS REALIZED MANUALLY, WITHOUT ANY TOOL. SO, THIS IS NOT POSSIBLE TO GENERATE A BEND AS SHOWN ABOVE IN LMO¿S MANUFACTURING PROCESS. MOREOVER, THE PICTURES SHOW THAT THE SPIGOT HAS BEEN DAMAGED (KNOCKS). THESE DAMAGES ARE TYPICAL AS A MISUSE WITH THE INSTRUMENT. THIS MISUSE LEAD TO A BENT OF THE LEG AND COULD GENERATE A BREAK OF THE LEG. 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

    CUSTOMER REPORTED TO MHRA THAT THE PLASTIC CENTRALISER FITTED TO STEM BUCKLED, SO WOULD NOT FIT THE STEM INTRODUCER. AN ALTERNATIVE WAS FOUND TO COMPLETE THE CASE. UPDATE: DELAY OF SURGERY 10 MIN.

    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

    CUSTOMER REPORTED TO (B)(6) THAT THE PLASTIC CENTRALISER FITTED TO STEM BUCKLED, SO WOULD NOT FIT THE STEM INTRODUCER. AN ALTERNATIVE WAS FOUND TO COMPLETE THE CASE. UPDATE: DELAY OF SURGERY 10 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377000 EXETER V40 STEM 50MM NO 1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH G7475555 04546540153364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other