BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX54OD

    MDR report key: 3834039 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19539
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 15, 2008
    Report Date
    October 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PFS AND MEDICAL RECORDS RECEIVED. THE PATIENT ALLEGES PAIN, HAVING TO USE A WALKER/CANE, AND UNABLE TO GO UP STAIRS. THE HEAD AND LINER ARE BEING REPORTED. AFTER REVIEW OF THE MEDICAL RECORDS IT SHOWS THE PATIENT HAD A POLY LINER. NO REVISION DATE HAS BEEN GIVEN. 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.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. THE PATIENT ALLEGES PAIN, HAVING TO USE A WALKER/CANE, AND UNABLE TO GO UP STAIRS. THE HEAD AND LINER ARE BEING REPORTED. AFTER REVIEW OF THE MEDICAL RECORDS IT SHOWS THE PATIENT HAD A POLY LINER. NO REVISION DATE HAS BEEN GIVEN. IF WE RECEIVE MORE MEDICAL RECORDS WE WILL UPDATE AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311460 PINN MAR +4 10D 36IDX54OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS INC US BS9CV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other