BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9249997 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112817
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    December 28, 2005
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. (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, ¿LONG-TERM RESULTS OF UNCEMENTED ACETABULAR CUPS WITH AN ACS POLYETHYLENE LINER. A 14¿16-YEAR FOLLOW-UP STUDY¿ BY E. GARCIA-REU, PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (2007), VOL. 31, PP. 205-210, WAS REVIEWED. THE AUTHORS ASSESSED CLINICAL AND RADIOGRAPHIC RESULTS OF 40 POROUS-COATED ACETABULAR CUPS WITH AN ACETABULAR CUP SYSTEM (ACS, DEPUY) POLYETHYLENE LINER OVER A MINIMUM 14-YEAR FOLLOW-UP. IMPLANTED PRODUCTS: ACS (TRILOCK AND PROFILE) CUPS AND LINERS, UNKNOWN DEPUY FEMORAL HEAD, DEPUY SCREWS FOR ACETABULAR CUP FIXATION, AND THE PROFILE FEMORAL STEM. RESULTS: FIFTEEN CUPS WERE REVISED, 11 DUE TO POLYETHYLENE LINER FRACTURE 15 INSTANCES OF PAIN ASSOCIATED WITH REVISION 3 DISLOCATIONS: 2 TREATED WITH CLOSED REDUCTION AND ONE LATE DISLOCATION WITH LINER REVISION DUE TO SEVERE WEAR UNSPECIFIED NUMBER OF HIPS WITH METALLOSIS IN REVISED LINER FRACTURE CASES 1 CUP REVISION FOR ASEPTIC LOOSENING 11 INSTANCES OF ACETABULAR OSTEOLYSIS ATTRIBUTED BY THE AUTHORS TO EXCESSIVE POLYETHYLENE WEAR. 18 MISPOSITIONED CUPS CONTRIBUTING TO FEMORAL HEAD PENETRATION AND POLYETHYLENE WEAR. MOST WERE NEEDED NO INTERVENTION. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE FEMORAL STEM. THE AUTHORS ATTRIBUTED THE REVISION FOR ACETABULAR LOOSENING TO PROGRESSIVE OSTEOLYSIS OF THE ACETABULUM. THE AUTHORS DO NOT SPECIFY PATIENT DATA WITH ADVERSE EVENTS. THE AUTHORS MENTION FINDING ¿METALLOSIS¿ IN SOME REVISED JOINTS BUT PROVIDE NO FURTHER INFORMATION REGARDING LOCATION OR TYPE OF METALLOSIS FOUND IN HIPS REVISED FOR FRACTURE OF THE POLYETHYLENE LINER. THE COMPONENT MATERIAL FOR THE FEMORAL HEAD IS UNKNOWN. THE SURGEONS ADDED AN UNKNOWN ABOUNT OF SCREWS TO SECURE SOME OF THE ACETABULAR CUPS DURING IMPLANTATION. THE SCREW IS CAPTURED IN THIS COMPLAINT FOR MISPOSITION AND ACETABULAR LOOSENING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043800 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention