BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX52OD

    MDR report key: 3012660 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14135
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. PATIENT REPORTS THAT SHE EXPERIENCES SQUEAKING AND DISASSOCIATION, AS WELL AS PAIN, BUT HAS NOT YET BEEN REVISED. DOI (B)(6) 2009 - DOR NOT YET REVISED (RIGHT HIP). UPDATE (B)(6) 2013 AND 05/24/(B)(6) WOULD CHANGE THE EXISTING MDR DECISION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. D. MEDICAL RECORDS WERE OBTAINED BUT DO NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED DISASSOCIATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT REPORTS THAT SHE EXPERIENCES SQUEAKING AND DISASSOCIATION, AS WELL AS PAIN, BUT HAS NOT YET BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115720 ALTRX +4 NEUT 36IDX52OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 C59A41000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention