BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9030921 · Received September 13, 2019

    Report

    Report Number
    1818910-2019-104408
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    January 1, 2018
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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, 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. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "DELAYED TOTAL HIP ARTHROPLASTY AFTER FAILED TREATMENT OF ACETABULAR FRACTURES: AN 8- TO 17-YEAR FOLLOW-UP STUDY" BY TAO WANG, JUN-YING SUN, JUN-JUN ZHA, CHAO WANG AND XI-JIANG ZHAO PUBLISHED BY THE JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH DOI.ORG/10.1186/S12018-018-0909-8 IN 2018 WAS REVIEWED FOR REPORTABILITY. THE PURPOSE: " THE PRIMARY AIM OF THE PRESENT STUDY WAS TO EVALUATE THE INFLUENCE OF THE MODE OF TREATMENT OF FRACTURE, CONSERVATIVE TREATMENT OR ORIF, ON THE CLINICAL OUTCOMES OF SALVAGE THA. THE SECONDARY AIM WAS TO EVALUATE THE LONG-TERM RESULTS ASSOCIATED WITH MODERN COC THA AFTER FAILED ACETABULAR FRACTURES." DATA INCLUDED 33 HIPS OF WHICH DEPUY S-ROM STEM AND DURALOC CUP WERE UTILIZED IN 12 HIPS FOR COC BEARING SURFACES. MEAN FOLLOW-UP TIME WAS 11.5 +_ 3.0 YEARS AND INITIAL THA IMPLANTS WERE FROM (B)(6) 1997 TO (B)(6) 2008. COMPLICATIONS POST THA IMPLANT : ACETABULAR REVISIONS DUE TO INFECTION & CERAMIC LINER FRACTURE (3 TOTAL). ADVERSE EVENTS: SURGICAL INTERVENTION, INFECTION, CERAMIC LINER FRACTURE. IMPACTED PRODUCTS: DEPUY DURALOC CUP, DEPUY DURALOC LINER (CERAMIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831478 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R