BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 4091867 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28149
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    March 24, 2014
    Report Date
    September 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Additional Manufacturer Narrative · 1

    (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

    UPDATE JUNE 05, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY LITIGATED, PATIENT ALLEGES UNABLE TO WORK, LIFT OR COMPLETE THE PHYSICAL ASPECTS OF HIS JOB. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ON THE OFFICE VISIT NOTE, PATIENT HAD COMPLAINED OF LEFT HIP PAIN AND SWELLING FOLLOWING A (B)(6) IN 2012. THE PATIENT ALSO FELT A SUDDEN POP IN HIS LEFT PROSTHESIS UPON SNEEZING AND COMPLAINED OF WORSENING LEFT HIP PAIN IN (B)(6) 2013. IT WAS ALSO REPORTED ON ONE OF THE OFFICE VISIT, AFTER EXPERIENCING A TRAUMATIC FALL AND DEVELOPED A HUGE HEMATOMA POSITIVE FOR STREPTOCOCCUS MITIS. PATIENT PROCEEDED TO EXPLANTATION OF HARDWARE ON (B)(6) 2014, HOWEVER PATIENT EXPERIENCED AN EPISODE OF DIPLOPIA AND VERTIGO WITH NO OCULAR FINDINGS. PREOPERATIVELY ON (B)(6) 2016. CONSULTATION WAS SOUGHT AND NEUROLOGY RECOMMENDED FOR FUTURE PROCEDURES WHICH IS ON (B)(6) 2014 TO FIND ANY EVIDENCE OF ONGOING INFECTION THAT WOULD REQUIRE TO ABORT INTENDED REIMPLANTATION AND INSTEAD PERFORM A SPACER EXCHANGE. LABORATORY RESULT INDICATES COBALT AND CHROMIUM BELOW 7UG/L. THERE IS NO REVISION NOTES PROVIDED. UPDATED THE PRODUCT INFORMATION. ADDED CUP, STEM, AND UNKNOWN SCREW. THIS COMPLAINT WAS UPDATED ON: JUNE 14, 2014.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573355 PINNACLE MTL INS NEUT36IDX58OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2136083

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other