BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 7918540 · Received September 28, 2018

    Report

    Report Number
    0002249697-2018-03118
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    August 31, 2018
    Report Date
    November 20, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327032314
    PMA / PMN Number
    K173499
    Removal / Correction Number
    2249697-08/29/2016-007R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING A METAL HEAD WAS REPORTED. DISASSOCIATION WAS CONFIRMED FOLLOWING A CLINICIAN REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: " X-RAY CONFIRMS DISASSOCIATION AND TRUNNION EROSION; NEED OPERATIVE REPORTS, CLINICAL AND PAST MEDICAL HISTORY AND EXAMINATION OF EXPLANTED COMPONENTS." DEVICE HISTORY REVIEW: ALL DEVICES 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. CONCLUSION: THE SUBJECT DEVICE HAS BEEN IDENTIFIED TO BE WITHIN SCOPE OF AN NC AND CAPA . LOT SPECIFIC VOLUNTARY RECALL RA 2016-028 WAS INITIATED FOR THE LFIT V40 COCR HEADS WITHIN SCOPE OF THE NC AND 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 ANALYSES 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. IF FURTHER INFORMATION BECOMES AVAILABLE AND/OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. PATIENT HAD COMPLAINED OF CLICKING FOR THE MONTH PRIOR. INTRAOPERATIVELY, NO BLACK TISSUE WAS NOTED, BUT THE TRUNNION WAS WORN TO A PERCEPTIBLE CONE. THE HEAD AND STEM WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND A METAL HEAD (LINER WAS NOT REVISED).

    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 REPORTED LOT. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. LOT SPECIFIC VOLUNTARY RECALL WAS INITIATED FOR THE LFIT V40 COCR HEADS WITHIN SCOPE OF A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. PATIENT HAD COMPLAINED OF CLICKING FOR THE MONTH PRIOR. INTRAOPERATIVELY, NO BLACK TISSUE WAS NOTED, BUT THE TRUNNION WAS WORN TO A PERCEPTIBLE CONE. THE HEAD AND STEM WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND A METAL HEAD (LINER WAS NOT REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760089 V40 COCR LFIT HEAD 36MM/+5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 89445901 07613327032314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R