BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2926123 · Received January 23, 2013

    Report

    Report Number
    1818910-2013-11355
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS A LINER THAT WAS NOT FULLY SEATED. DOI (B)(6) 2009 - DOR (B)(6) 2013 (HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. 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

    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

    (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 A LINER THAT WAS NOT FULLY SEATED.

    Description of Event or Problem · 1

    UPDATE MAY 17, 2017: LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, LIMITATIONS AND ELEVATED LEVELS OF CHROMIUM AND COBALT. ADDED THE HEAD FOR THE ALLEGED PAIN AND STEM FOR THE ALLEGED ELEVATED ION LEVELS, ALSO ADDED THE COMPLAINANT INFORMATION AND THE CORRECT IMPLANT SIDE. THERE ARE NO MEDICAL AND LABORATORY VALUES PROVIDED FOR THE ALLEGED ELEVATED IONS. THIS COMPLAINT WAS UPDATED ON: MAY 25, 2017.

    Description of Event or Problem · 1

    UPDATE SEP 19, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DISCOMFORT, TISSUE DAMAGE, LEG LENGTH DISCREPANCY. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED PATIENT WAS REVISED PROBABLE METAL HYPERSENSITIVITY. REVISION NOTES REPORTED REACTIVE SYNOVITIS, NO OVERT METALLOSIS, NO GROSS INSTABILITY. IT WAS ALSO STATED THAT THE METAL LINER WAS NOT FULLY SEATED IN THE LOCKING MECHANISM. THIS COMPLAINT WAS UPDATED ON OCT 12, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32288 PINNACLE MTL INS NEUT36IDX52OD ACETABULAR LINER KWA DEPUY INTERNATIONAL LTD. 8010379 2877696

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention