BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9181108 · Received October 11, 2019

    Report

    Report Number
    1818910-2019-109422
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    November 1, 2014
    Report Date
    September 18, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. 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: 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "SURGICAL TECHNIQUE AND OUTCOME OF UNCEMENTED THR USING HA COATED STEMS IN FUSED AND DEFORMED HIPS DUE TO ANKYLOSING SPONDYLITIS" WRITTEN BY SUNDARESH DABIR, SHARATH RAMANATH, HARSHAD SHAH, MADHUKESH RUDRAMURTHY, AND SANJANA S. PATIL PUBLISHED BY HIP INT 2015; 25 (2): 142-145 DOI: 10.5301/HIPINT.5000197 ON 1 NOVEMBER 2014 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE REPORTS ON PATIENTS WHO RECEIVED UNCEMENTED POROUS COATED DEPUY DURALOC TITANIUM CUPS WITH DEPUY MARATHON HIGHLY CROSS LINKED POLY LINER AND HYDROXYAPATITE COATED DEPUY CORAIL STEMS. A TOTAL OF 4 PATIENTS HAD A BREACH IN MEDIAL WALL OF THE ACETABULUM DURING REAMING AND RECEIVED BONE GRAFTING ON THE MEDIAL WALL BEFORE CUP INSERTION. ONE PATIENT WAS NOTED TO 56 DEGREE INCLINATION. ONE PATIENT HAD A POSTERIOR DISLOCATION OF THE HIP AND TREATED BY CLOSED REDUCTION AND TRACTION APPLIED FOR 3 WEEKS AFTER REDUCTION. BLOOD TRANSFUSION WAS REQUIRED BY 2 PATIENTS. 3 PATIENTS HAD LEG LENGTH DISCREPANCY OF .5 CM AND MANAGED WITH SHOE RISE. THE ARTICLE DOES NOT IDENTIFY THE FEMORAL HEAD. ADVERSE EVENTS: ACETABULAR FRACTURE RECEIVING INTRAOPERATIVE TREATMENT, MISPOSITIONED CUP, DISLOCATION WITH TREATMENT, MAJOR BLEED, LIMB ASYMMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972082 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention