BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 44IDX62OD

    MDR report key: 4336451 · Received December 17, 2014

    Report

    Report Number
    1818910-2014-34346
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    January 15, 2013
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. 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. (B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. THE PPD ALLEGES THE PATIENT WAS REVISED ON (B)(6) 2013 FOR INFECTION. NO OPERATIVE NOTE INCLUDED, ONLY STICKER SHEETS AND THE PATIENT IMPLANTED WITH NEW IMPLANTS ON (B)(6) 2013 (EXCEPT THE CUP WASN¿T REVISED). THE STEM THAT WAS REMOVED DURING THIS REVISION HAS ALREADY BEEN REPORTED ON (B)(6) . THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826663 ALTRX +4 NEUT 44IDX62OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 135714

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention