BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 6973122 · Received October 24, 2017

    Report

    Report Number
    0002249697-2017-03086
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 25, 2017
    Report Date
    January 5, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EXPIRATION DATE, UNIQUE IDENTIFIER #; MANUFACTURING DATE. AN EVENT REGARDING FOREIGN MATERIAL INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION OF THE RETURNED DEVICE NOTED A RESIDUE/FOREIGN BODY ON THE STEM THAT IS INSIDE THE INNER BLISTER. A MAR OF THE RETURNED DEVICE CONCLUDED [...] REVIEW OF THE V40 STEM FEMORAL COMPONENT, CATALOGUE # 0580-1-440, LOT CODE G6106997 CONFIRMED PARTICLE ON THE FEMORAL STEM. CHARACTERISATION USING STEREO MICROSCOPY AND ELECTRON MICROSCOPY CONFIRMED PARTICLE TO CONTAIN ELEMENTS OF CARBON OXYGEN, WHICH WOULD INDICATE THE MATERIAL IS POLYMERIC BASED [...] MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THERE WAS NO PATIENT INVOLVEMENT. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: AN NC HAS BEEN RAISED TO INVESTIGATE THE EVENT. A MATERIAL ANALYSIS WAS PERFORMED THROUGH THE INVESTIGATION. THE MATERIAL ANALYSIS CONCLUDED "REVIEW OF THE EXETER V40 STEM FEMORAL COMPONENT, CATALOGUE # 0580-1-440, LOT CODE G6106997 CONFIRMED PARTICLE ON THE FEMORAL STEM. CHARACTERISATION USING STEREO MICROSCOPY AND ELECTRON MICROSCOPY CONFIRMED PARTICLE TO CONTAIN ELEMENTS OF CARBON OXYGEN, WHICH WOULD INDICATE THE MATERIAL IS POLYMERIC BASED MATERIAL. " CONSULTATION WITH THE SUPPLIER LISI MEDICAL ORTHOPAEDICS (LMO) AS PART OF THE INVESTIGATION INDICATED; THERE IS A 100% VISUAL INSPECTION OF THE DEVICE AT THE PACKAGING STEP. NO MANUFACTURING CHANGES OCCURRED IN THE PROCESS -4290 EXETER STEMS WERE RE-INSPECTED IN JUNE 2017 PART OF AN FOR A STAIN ISSUE, AND NO ISSUE WAS NOTED ON ANY OF THE STEMS INSPECTED (NO FOREIGN MATERIAL FOUND). LISI MEDICAL ORTHOPAEDICS OPENED AN NCR TO FURTHER INVESTIGATE THE CAUSE OF THIS ISSUE AND IMPLEMENT THE REQUIRED CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SCRUB NURSE WAS OPENING UP THE EXETER STEM, A SMALL FOREIGN BODY COULD BE SEEN THROUGH THE PLASTIC STERILE LAYER. ANOTHER DEVICE WAS ON HAND TO COMPLETE THE CASE. THE DEVICE REMAINED UNOPENED AND DID NOT ENTER THE STERILE FIELD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SCRUB NURSE WAS OPENING UP THE EXETER STEM, A SMALL FOREIGN BODY COULD BE SEEN THROUGH THE PLASTIC STERILE LAYER. ANOTHER DEVICE WAS ON HAND TO COMPLETE THE CASE. THE DEVICE REMAINED UNOPENED AND DID NOT ENTER THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752415 EXETER V40 STEM 44MM NO 0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH G6106997

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other