BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 37.5MM NO 3

    MDR report key: 6600596 · Received May 31, 2017

    Report

    Report Number
    0002249697-2017-01729
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 2, 2017
    Report Date
    September 18, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540153272
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A MISSING SPIGOT PROTECTOR FOR AN EXETER STEM WAS REPORTED. THE SPIGOT WAS NOT RETURNED IN THE PACKAGING, HOWEVER THE EVENT COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED PART. THE PHOTOGRAPH NOTED THAT THE SPIGOT WAS MISSING AS WAS SOME OF THE PACKAGING FOAM. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO ADVERSE CONSEQUENCES TO THE PATIENT WERE NOTED AND NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION PERFORMED BY THE SUPPLIER CONCLUDED "NO ACTION IS REQUIRED AT THIS TIME AS THERE WAS NO INDICATION OF A MANUFACTURING ISSUE. THIS COMPLAINT WAS PRESENTED TO THE EXETER STEM PACKAGING OPERATORS. LMO QA PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS". NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    WHEN THE STEM PACKAGE WAS OPENED DURING SURGERY, IT WAS NOTICED THAT THE SPIGOT AT THE NECK WAS NOT IN THE PACKAGE. THERE WAS NO SURGICAL DELAY BECAUSE THE STAFF JUST OPENED ANOTHER STEM PACKAGE.

    Description of Event or Problem · 1

    WHEN THE STEM PACKAGE WAS OPENED DURING SURGERY, IT WAS NOTICED THAT THE SPIGOT AT THE NECK WAS NOT IN THE PACKAGE. THERE WAS NO SURGICAL DELAY BECAUSE THE STAFF JUST OPENED ANOTHER STEM PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381241 EXETER V40 STEM 37.5MM NO 3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 0580-1-373 G6169618 04546540153272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other