BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 8749736 · Received July 1, 2019

    Report

    Report Number
    1818910-2019-97274
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 11, 2019
    Report Date
    June 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    MRA
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: FOLLOWING REVIEW OF THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT IT WAS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. THE COMPLAINT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE REVIEWED AND FURTHER INVESTIGATION COMPLETED AS REQUIRED. DEVICE HISTORY LOT: 8747546. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: PRODUCT CODE 121881752, WORK ORDER (B)(4) WAS MANUFACTURED ON 24-FEBRUARY-2018. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION.THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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.  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

    (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

    1218-81-762 CERAMIC INSERT CRACKED ON IMPACT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 10 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? --> REMOVE BROKEN PIECES AND REPLACED WITH NEW INSERT, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543199 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS, INC. 1818910 8747546

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention