BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX60OD

    MDR report key: 3030103 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-14715
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    May 6, 2013
    Report Date
    August 13, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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

    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

    THE 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

    UPDATE: (B)(4) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    MAUDE REPORT (MW5029341) SUBMITTED BY A PATIENT STATES THAT HE HAS EXPERIENCED PAIN, AND RECENTLY UNDERWENT A BLOOD TEST WHICH SHOWED AN ELEVATED COBALT LEVEL OF 8.5. HE HAS NOT YET BEEN REVISED. UPDATE: 5/13/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES BODILY INJURY AND SUFFERING. LITIGATION HAS PROVIDED A DATE OF REVISION. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. (LITIGATION HAS BEEN ATTACHED TO THE COMPLAINT.) UPDATE 05/06/2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN, SIGNIFICANT SYNOVIAL INFLAMMATION, TRUNNION BURNISHING, AND METALLOSIS. IT WAS ALSO REPORTED THAT THE CUP PLACEMENT WAS NOT OPTIMAL. BASED ON THIS REPORT, TWO ADDITIONAL PRODUCTS HAVE BEEN ADDED. UPDATE: 8/13/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOI (B)(6) 2008 - DOR: (B)(6) 2013 (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES A4BEK1000 AND ZS5FV1000 . A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2347172 AND 2436882 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    MAUDE REPORT (B)(4) SUBMITTED BY A PATIENT STATES THAT HE HAS EXPERIENCED PAIN, AND RECENTLY UNDERWENT A BLOOD TEST WHICH SHOWED AN ELEVATED COBALT LEVEL OF 8.5. HE HAS NOT YET BEEN REVISED.

    Description of Event or Problem · 1

    ** UPDATE ** (B)(4) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN, SIGNIFICANT SYNOVIAL INFLAMMATION, TRUNNION BURNISHING, AND METALLOSIS. IT WAS ALSO REPORTED THAT THE CUP PLACEMENT WAS NOT OPTIMAL. BASED ON THIS REPORT, TWO ADDITIONAL PRODUCTS HAVE BEEN ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134088 PINNACLE MTL INS NEUT40IDX60OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC US 2347172

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention