BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3001846 · Received March 13, 2013

    Report

    Report Number
    1818910-2013-13695
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPDATED: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Description of Event or Problem · 1

    UPDATE JUL 05, 2017: MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED , PFS ALLEGES WEAKNESS, LOSS OF MOBILITY, METALLOSIS, TISSUE NECROSIS, STIFFNESS AND NUMBNESS, DERMATITIS, TINNITUS, ESOPHAGEAL SPASM, AND BURSITIS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. REVISION NOTES STATED THAT THERE WAS MINIMAL FLUID WITHIN THE HIP JOINT BUT NO TISSUE NECROSIS FOUND. EXAMINATION NOTES REPORTED THAT PATIENT SUFFERED FROM TROCHANTERIC BURSITIS. MRI SHOWED A FLUID COLLECTION AT THE POSTERIOR ASPECT OF THE FEMORAL NECK. LABORATORY RESULTS FOR COBALT- CHROMIUM LEVELS WERE ABOVE 7 PPB. ADDED STEM TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON JUL 13, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104966 PINNACLE MTL INS NEUT36IDX50OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 2760509

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention