BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 11171882 · Received January 14, 2021

    Report

    Report Number
    1818910-2021-01120
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    November 10, 2020
    Report Date
    January 7, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016410
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(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 ==> A DEVICE MANUFACTURING (MRE) REVIEW WILL NOT BE PERFORMED EVEN WHEN PRODUCT/LOT INFORMATION IS KNOWN. PER WI-3430 IT HAS BEEN DETERMINED THAT, FOR THE MOM PLATFORM AND RELATED ALLEGATIONS AN MRE IS NOT REQUIRED. H10 ADDITIONAL NARRATIVE: CORRECTED: D1, D2, D4 (CATALOG), D10 AND H6 (DEVICE CODE) THE DEVICE CODE NATURALLY WORN IS BEING REPORTED AGAIN TO CAPTURE THE UPDATED CODE FROM IMPLANT BEARING WEAR-POLY TO IMPLANT BEARING WEAR - METAL. THE PREVIOUS REPORTED MEDICAL DEVICE ALTRX +4 10D 36IDX54OD; PRODUCT CODE: 122136154, LOT NUMBER: J84U21, PROCODE: LPH/K072963 AND DEVICE MANUFACTURE DATE: 6/30/2020 ARE BEING RETRACTED AS PER ADDITIONAL INFORMATION THAT THE PRIMARY SURGERY WAS REPORTED AS CALENDAR YEAR 2009. THE LINER, REPORTED AS WORN, WAS NOT MANUFACTURED UNTIL YEAR 2020. THE DEVICE COULD NOT HAVE BEEN IMPLANTED IN 2009.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5 AND H6 (PATIENT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    REVISION OPERATIVE NOTES (B)(6) 2020, INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RIGHT HIP PAIN, ADVERSE LOCAL TISSUE REACTION, POLY LINER WEAR AND OSTEOLYSIS OF PROXIMAL FEMUR AND ACETABULUM. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. UPON ENTERING THE JOINT A MASSIVE PSEUDOTUMOR WAS ENCOUNTERED ALONG WITH OSTEOLYSIS. CORROSION WAS NOTED ON THE FEMORAL STEM TRUNNION, POLYWEAR WAS NOTED ON THE LINER. BLOOD LOSS OF 1,000ML WAS NOTED, CELL SAVER WAS UTILIZED AND RETURNED 400ML OF THE PATIENTS OWN BLOOD BACK TO THEM.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE EVENT DESCRIPTION STATES THAT THE METALLOSIS AND AVAL WAS SECONDARY TO WEAR OF THE POLYETHYLENE LINER. IT IS BELIEVED THAT THE LINER WORE THROUGH, CAUSING ARTICULATION OF THE FEMORAL HEAD ON THE METAL SHELL. FOLLOW-UP IS BEING CONDUCTED TO VERIFY THE SOURCE OF THE METALLOSIS AND AVAL. 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

    CLINICAL ADVERSE EVENT RECEIVED FOR LINER FAILURE - WEAR AND METALLOSIS, ALVAL, KIPPEL TRENAUNAY SYNDROME EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2009. DATE OF EVENT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2020. (RIGHT HIP). REVISION OF METAL HEAD AND LINER. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70852 UNKNOWN HIP ACETABULAR LINERS PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1221-36-154 J84U21 10603295016410

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ALTRX +4 10D 36IDX54OD.| CORAIL2 LAT COXA VARA SIZE 11.| DLT TS CER HD 12/14 36MM +5.0.| PINNACLE 100 ACET CUP 54MM.| UNKNOWN HIP FEMORAL HEAD.