BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 7905102 · Received September 25, 2018

    Report

    Report Number
    1818910-2018-70315
    Event Type
    Injury
    Date Received
    September 25, 2018
    Report Date
    August 29, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LZO
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE DEVICES WERE REVIEWED AND A REPORT WAS RECEIVED STATING IT IS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT AND AS STATED IN THE LAB REPORT, A COMBINATION OF CIRCUMSTANCES HAVE POTENTIALLY LED TO THE FAILURE MODE REPORTED IN THIS COMPLAINT. IT IS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. NO CORRECTIVE ACTION IS REQUIRED ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT PRODUCT CODE 136536310, WORK ORDER 2570772 WAS MANUFACTURED ON 28TH FEBRUARY 2008. 21 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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 · 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). CONCOMITANT MED PRODUCTS: UNKNOWN HIP FEMORAL HEAD; PINNACLE MTL INS NEUT (B)(4) HIP ACETABULAR LINER; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RETURNED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 2539888. DEVICE HISTORY REVIEW: 20 PRODUCTS WERE MANUFACTURED AND PLACED INTO STOCK ON 26 JAN 2008. NO ANOMALIES IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HIP FEMORAL HEAD; PINNACLE MTL INS NEUT 36IDX50OD HIP ACETABULAR LINER; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BFARM: METALLOSIS WITH WEAR OF INLAY. IT WAS NOT POSSIBLE TO DISSOLVE THE INLAY FROM THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748711 DELTA CER HEAD 12/14 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS, INC. 1818910 2570772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention