BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9323302 · Received November 14, 2019

    Report

    Report Number
    1818910-2019-113398
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    May 1, 2003
    Report Date
    October 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (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

    LITERATURE ARTICLE ENTITLED, ¿DISLOCATION AFTER REVISION OF HEMIARTHROPLASTY TO TOTAL HIP REPLACEMENT¿ BY L. MIRANDA V. CHAMPION AND SCARLETT A. MCNALLY, PUBLISHED BY INJURY: INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED (2004), VOL. 35, PP. 161-164, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO REVIEW THE INCIDENCE OF DISLOCATION AFTER REVISION OF FAILED HEMIARTHROPLASTIES USING A COMPETITOR STEM. THIS ARTICLE PROVIDES DETAILED PATIENT AND REVISION INFORMATION. THIS COMPLAINT WILL CAPTURE THE 2 PATIENTS WHO, AFTER IMPLANTATION WITH DEPUY CHARNLEY THAS, EXPERIENCED POSTOPERATIVE DISLOCATIONS. THERE WERE TWO ADDITIONAL PATIENTS IMPLANTED WITH CHARNLEY THAS WHO EXPERIENCED NO COMPLICATIONS OR REVISIONS. THESE CASES WILL NOT BE INCLUDED IN THIS COMPLAINT. THE TWO CASES WITH COMPLICATIONS ARE LABELED CASE 1 PATIENT 3 AND CASE 2 PATIENT 7. THIS PC WILL CONTAIN 2 TOTAL PCS. CASE ONE IS INCLUDED WITH THE PARENT PC-000578195. CASE 2 WILL BE INCLUDED ON A SEPARATE PC TO BE LINKED TO THE PARENT PC. CAPTURED IN THIS COMPLAINT: CHARNLEY POLYETHYLENE CUP AND UNKNOWN FEMORAL HEAD FOR JOINT DISLOCATION. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE CHARNLEY STEM IN EITHER CASE. (B)(6) PATIENT WITH COMPETITOR STEM HEMIARTHROPLASTY WAS CONVERTED TO A CHARNLEY THA- POLYETHYLENE CUP, FEMORAL HEAD, AND STEM 11 MONTHS AFTER INDEX SURGERY DUE TO A LOOSENING NATURAL ACETABULUM. THE PATIENT EXPERIENCED A DISLOCATION 12 DAYS AFTER THA CONVERSION. TREATED WITH CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115097 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention