BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUR OPT STD POLY INS 28/48,50

    MDR report key: 6661068 · Received June 22, 2017

    Report

    Report Number
    1818910-2017-19956
    Event Type
    Death
    Date Received
    June 22, 2017
    Date of Event
    March 20, 2017
    Report Date
    May 24, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    UDI-DI
    10603295065593
    PMA / PMN Number
    K040544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. 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). 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 BATCH: 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

    PATIENT WAS REVISED TO ADDRESS INSTABILITY AND CUP MALPOSITION. DISLOCATION, IMPINGEMENT OF THE STEM AND CUP, METALLOSIS AND FRETTING OF THE TAPER WAS ALSO NOTED. UPDATE 04/10/2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY THE REVISION OPERATIVE NOTE INDICATED METALLOSIS, DISLOCATION, MALPOSITIONED CUP/STEM (SLIGHT RETROVERSION), INSTABILITY, AND IMPINGEMENT. THERE WAS NO MENTION OF FRETTING ON THE TAPER. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 05/02/2017. UPDATE MAY 23, 2017: CLAIM LETTER RECEIVED. CLAIM LETTER STATES THAT THE PATIENT SUFFERED FROM COBALT TOXICITY AND WAS THE CAUSE OF HER DEATH. IT WAS ALSO REPORTED THAT DURING THE REVISION, THE SURGEON OBSERVED MASSIVE METALLOSIS OF THE SOFT TISSUES AND A LARGE AMOUNT OF MOTOR-OIL APPEARING FLUID. IT WAS CONFIRMED THAT THE LAB RESULTS FOR SERUM COBALT LEVEL WAS 370 UG/L. HEAD AND LINER HAVE BEEN ADDED DUE TO ALLEGED COBALT TOXICITY. THE LETTER DEMAND FOR PRESERVATION OF EVIDENCE. PRODUCT CODES AND LOT NUMBERS WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON MAY 24, 2017. UPDATE MAY 24, 2017: CLAIM LETTER RECEIVED. AFTER REVIEW OF CLAIM LETTERS, THERE IS NO NEW INFORMATION. THIS COMPLAINT WAS UPDATED ON MAY 26, 2017. UPDATE JUN 08, 2017: CLAIM LETTER RECEIVED. CLAIM LETTER DEMANDED FOR PRESERVATION OF EVIDENCE, DEATH FROM COBALT TOXICITY DUE TO DEPUY HIP PROSTHESIS. THIS COMPLAINT WAS UPDATED ON JUN 1, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440541 DUR OPT STD POLY INS 28/48,50 HIP ACETABULAR INSERT/LINER LPH DEPUY INTERNATIONAL LTD - 8010379 3025048 10603295065593

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death