BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +1 GR

    MDR report key: 3834223 · Received May 28, 2014

    Report

    Report Number
    1818910-2014-19551
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    October 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    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. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PFS AND STICKER SHEET RECEIVED. PATIENT ALLEGED DIFFICULTY WALKING AND CLIMBING STAIRS AND HAVING A LIMP. HE ALLEGES THESE PROBLEMS ARE RELATED TO HIS PINNACLE IMPLANT. THE HEAD AND LINER ARE BEING REPORTED. AFTER REVIEW OF THE STICKER SHEET IT REVIEWED THE PATIENT HAD A POLY LINER IMPLANTED. THE PATIENT HASN¿T BEEN REVISED YET. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PFS AND STICKER SHEET RECEIVED. PATIENT ALLEGED DIFFICULTY WALKING AND CLIMBING STAIRS AND HAVING A LIMP. HE ALLEGES THESE PROBLEMS ARE RELATED TO HIS PINNACLE IMPLANT. THE HEAD AND LINER ARE BEING REPORTED. AFTER REVIEW OF THE STICKER SHEET IT REVIEWED THE PATIENT HAD A POLY LINER IMPLANTED. THE PATIENT HASN¿T BEEN REVISED YET. IF WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313043 ARTICUL/EZE BALL 32 +1 GR HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1033462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other