BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +1

    MDR report key: 8941361 · Received August 28, 2019

    Report

    Report Number
    1818910-2019-102434
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033431
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT PATIENT WAS DISLOCATING. SURGEON REMOVED LINER AND CONVERTED TO 36 PINNACLE LINER. KEPT EXISTING STEM 155401135, L- 182329, 121722054, L- 180557. DOI: (B)(6) 2013; DOR: (B)(6) 2019; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736400 DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 6812096 10603295033431

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention