BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/+8

    MDR report key: 6089927 · Received November 9, 2016

    Report

    Report Number
    0002249697-2016-03541
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    January 24, 2016
    Report Date
    January 26, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    2249697-08/29/2016-007R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ACUTE HIP DISLOCATION INVOLVING A V40 COCR HEAD WAS REPORTED. IT WAS DETERMINED THAT THE HEAD DISASSOCIATED FROM THE STEM. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: DAMAGES CONSISTENT WITH EXPLANATION DAMAGES AND A LOSS OF TAPER LOCK WERE OBSERVED ON THE ACCOLADE STEM AND V40 HEAD. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE SUBJECT DEVICE HAS BEEN IDENTIFIED TO BE WITHIN SCOPE A CAPA . LOT SPECIFIC VOLUNTARY RECALL RA 2016-028 WAS INITIATED FOR THE LFIT V40 COCR HEADS UNDER THE SCOPE OF THIS CAPA. THE INVESTIGATION REVEALED THAT ONLY SPECIFIC CATALOG NUMBERS AND SPECIFIC LOTS ARE IMPACTED BY THE REGULATORY ACTION AND THAT THE AFFECTED LOTS WERE MANUFACTURED ON OR BEFORE MARCH 4, 2011. THE ROOT CAUSE ANALYSIS IDENTIFIED A PROCESS RELATED ANOMALY AS TO THE AFFECTED SIZES AND LOTS. THE AFFECTED PRODUCT HAS ALL BEEN IMPLANTED AND/OR EXPIRED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH ACUTE HIP DISLOCATION. FEMORAL HEAD, STEM AND INSERT WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740242 V40 COCR LFIT HEAD 40MM/+8 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH LN8MMA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R