BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX66OD

    MDR report key: 3970698 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24670
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    September 7, 2012
    Report Date
    August 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    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

    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. 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.

    Additional Manufacturer Narrative · 1

    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

    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. DEVICE HISTORY LOT: NULL. DEVICE HISTORY LOT: NULL. DEVICE HISTORY REVIEW: NULL. 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

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN.

    Description of Event or Problem · 1

    UPDATE APR 19, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS EXPERIENCING OSTEOLYSIS AND TISSUE FIBROSIS. THE DATA WAS COLLECTED DURING THE REVISION ON (B)(6) 2009 (PRIOR SURGERY). THIS COMPLAINT WAS UPDATED ON APR 26, 2017.

    Description of Event or Problem · 1

    UPDATE MAY 05, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN CONSTANT WITH STIFFNESS, NUMBNESS AND WEAKNESS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS FOUND ON THE OPERATIVE NOTES THAT THERE WAS A SIGNIFICANT HETEROTOPIC OSSIFICATION. THERE IS NO LABORATORY VALUES PROVIDED. THIS COMPLAINT WAS UPDATED ON: MAY 17, 2017.

    Description of Event or Problem · 1

    UPDATE JUN 06, 2017: SUPPLEMENTAL INFORMATION RECEIVED. AFTER REVIEW OF SUPPLEMENTAL INFORMATION THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE EXISTING MDR DECISION. LABORATORY FINDINGS INDICATES FRACTURED FEMORAL HEAD COMPONENTS. THERE IS NO GROSS EVIDENCE OF DISLOCATION. THIS COMPLAINT WAS UPDATED ON: JUN 12, 2017.

    Description of Event or Problem · 1

    UPDATE JUN 27, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR REPORTABILITY. ADDED LABORATORY FINDINGS. THIS COMPLAINT WAS UPDATED ON: JUN 30, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446382 PINNACLE MTL INS NEUT44IDX66OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2452993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention