BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 32IDX60OD

    MDR report key: 3940631 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23655
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    January 7, 2014
    Report Date
    July 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR. A DUPLICATE REPORT HAS BEEN PREVIOUSLY SUBMITTED FOR THIS PRODUCT IN (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT MAY BE RE-OPENED AND UPDATED IN (B)(4).

    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.

    Description of Event or Problem · 1

    CASE REPORTED TO (B)(4) BY (B)(6). DESCRIPTION OF THE EVENT PROVIDED AS FOLLOWS: CLINICAL NOTES INDICATE THAT THE PATIENT SUFFERED A DISLOCATED ACETABULAR CUP LINER ON THE RIGHT SIDE OF THEIR DEPUY CORAIL PINNACLE TOTAL HIP REPLACEMENT PROSTHESIS IN (B)(6) 2014, AFTER UNDERGOING A BILATERAL TOTAL HIP REPLACEMENT IN (B)(6) 2013. ON THE RIGHT SIDE OF THE PROSTHESIS, CEMENT-LESS IMPLANTS WERE USED WITH A PLASTIC LINER IN A METAL SHELL, AND A 32MM HEAD. PATIENT WAS MAKING A SATISFACTORY RECOVERY UNTIL HE EXPERIENCED INSTABILITY AND X-RAYS SUBSEQUENTLY REVEALED A DISPLACEMENT OF THE PLASTIC LINER IN THE SHELL. REVISION SURGERY WAS UNDERTAKEN TO REPLACE THE LINER AND FEMORAL HEAD. (B)(6) REQUESTS THE REPORTED EVENT TO BE INVESTIGATED BY THE MANUFACTURER AND THE FOLLOWING QUERIES ADDRESSED: DOES THE MANUFACTURER OF THE DEVICE HAVE ANY COMMENTS REGARDING COMPLAINTS OF THIS TYPE? IS THERE ANY ADDITIONAL INFORMATION THAT YOU WISH TO PROVIDE THAT MAY ASSIST (B)(6) WITH THIS INVESTIGATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419875 PINN MAR NEUT 32IDX60OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC.1818910 386657

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention