BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9154284 · Received October 3, 2019

    Report

    Report Number
    1818910-2019-107393
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    January 4, 2016
    Report Date
    September 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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, "COMPARATIVE CLINICAL STUDY OF THE PROPHYLAXIS OF HETEROTOPIC OSSIFICATIONS AFTER TOTAL HIP ARTHROPLASTY USING ETORICOXIB OR DICLOFENAC" WRITTEN BY SEBASTIAN WINKLER & HANS-ROBERT SPRINGORUM & TOBIAS VAITL & MARTIN HANDEL & SABINE BARTA & VICTORIA KEHL & BENJAMIN CRAIOVAN & JOACHIM GRIFKA PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) (2016) 40:673¿680 DOI 10.1007/S00264-015-3077-Z ON 4 JANUARY 2016 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE IDENTIFIES DEPUY CORAIL AND PINNACLE PRODUCTS UTILIZED THE DATA FROM THIS STUDY WAS EXTRACTED FROM 100 PATIENTS FOCUSING ON INCIDENTS OF HETEROTOPIC OSSIFICATION AND THE EFFECTIVENESS OF DICLOFENAC VERSE ETORICOXIB IN PREVENTING HETEROTOPIC OSSIFICATION (HO). THE ARTICLE REPORTS A TOTAL OF 34 PATIENTS TOTAL WITH HETEROTOPIC OSSIFICATION DETECTED. THE ARTICLE ALLEGATES THAT AN INCREASE OF HO FORMATION MOST LIKELY DECREASES HIP ABDUCTION AND INTERNAL ROTATION. ADVERSE EVENTS OF POST-OPERATIVE PAIN, NAUSEA, VOMITING, DIZZINESS AND DIARRHEA WERE CORRELATED TO THE STUDY MEDICATIONS. FURTHER INCIDENCES WERE CATEGORIZED AS SERIOUS ADVERSE EVENTS (WITHIN 6 MONTHS POST OP) AND NOT TO BE RELATED TO THE STUDY MEDICATION: A POST-OPERATIVE LYMPHADENECTOMY, A THROMBOSIS, PULMONARY EMBOLISM, RIB FRACTURE AND A POST-OPERATIVE SEROMA. ALL PATIENTS HAD A FULL RECOVERY AND THE ARTICLE DOES NOT CLARIFY IF THE PATIENTS RECEIVED INTERVENTIONS FOR THE SERIOUS ADVERSE EVENTS. THE ARTICLE GIVES NO FURTHER INFORMATION REGARDING OF ANY REVISIONS OR PERFORMANCE OF DEPUY PRODUCTS AND FOCUSED ON OUTCOMES RELATED TO MEDICATION STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948235 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention