BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 9/10 14X9X125 30+4

    MDR report key: 8160413 · Received December 13, 2018

    Report

    Report Number
    1818910-2018-78073
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 16, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICES WERE REVIEWED BY BIOENGINEERING AND A REPORT WAS RECEIVED STATING IT WAS UNLIKELY THAT A MANUFACTURING DEFECT WAS PRESENT. 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: DHR REVIEW: PRODUCT CODE: 900549210, LOT NUMBER: 2834334 WAS MANUFACTURED ON 22 JAN 2009. 28 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO NCS/DEVIATION ASSOCIATED WITH THIS LOT. 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.

    Additional Manufacturer Narrative · 1

    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 THE SURGEON RECOGNIZED THAT THERE WAS LOOSENESS ON THE PATIENT'S RIGHT HIP JOINT, OSTEOLYSIS ON THE CUP OF AROUND SCREWS. ALSO, THERE WAS SUSPECTED ARMD BECAUSE OF THE LINER AND THE HEAD WERE SUNK. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE LINER (P/N: 121887352), THE HEAD (P/N: 962712000), THE STEM (P/N: 900549210) WITH SLEEVE (P/N: 550502). THERE WAS NO CORROSION BETWEEN THE LINER AND THE CUP HOWEVER, THERE WAS CORROSION EVIDENTLY BETWEEN THE HEAD AND THE STEM. THE SURGERY WAS COMPLETED WITHOUT ANY OTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001678 SROM 9/10 14X9X125 30+4 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY INTERNATIONAL LTD. 8010379 2834334

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention