BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 10946514 · Received December 4, 2020

    Report

    Report Number
    1818910-2020-26166
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    July 31, 2010
    Report Date
    November 16, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ABSTRACT ENTITLED, ¿INCIDENCE OF DEEP INFECTION IN ASEPTIC REVISION THA USING VANCOMYCIN-IMPREGNATED IMPACTED BONE ALLOGRAFT¿ BY MARTIN A. BUTTARO, ET AL; PUBLISHED BY HIP INTERNATIONAL (2010), VOL. 20, NO. 04, PP. 535-541, WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE RECURRENCE OF PERIPROSTHETIC INFECTION AFTER REVISION SURGERY PREFORMED WITH ANTIBIOTIC IMPREGNATED BONE ALLOGRAFT IN 80 REVISIONS PERFORMED BETWEEN JAN 2002 AND OCTOBER 2005. 30 CASES WERE IMPLANTED WITH A COMPETITOR CONSTRUCT. 30 CASES WERE IMPLANTED WITH A DEPUY OGEE POLYETHYLENE CUP, C STEM, CMWI CEMENT, AND AN UNKNOWN DEPUY HEAD. THE AUTHORS DO NOT PROVIDE RESULTS SPECIFIC TO MANUFACTURER THEREFORE, ALL RESULTS WILL BE INCLUDED. THE EXACT NUMBER OF DEPUY PRODUCTS INVOLVED IN THE FOLLOWING EVENTS IS UNKNOWN. RESULTS: CASE #44: PATIENT EXPERIENCED A HEMATOGENOUS INFECTION SECONDARY TO A DENTAL ABSCESS WHICH WAS TREATED WITH AN I&D. THE PROCEDURE WAS UNSUCCESSFUL. THE PATIENT WAS SUBSEQUENTLY REVISED WITH A TWO-STAGE REVISION TO TREAT MRSA INFECTION AND LOOSENING OF THE CUP AND STEM. (CEMENT, CUP, HEAD, STEM) 3 CASES OF PERIPROSTHETIC FRACTURE TREATED WITH SURGICAL FIXATION. IT IS UNKNOWN IF THE FRACTURES OCCURRED IN THE ACETABULUM OR THE FEMUR. 2 REVISION TO TREAT RECURRENT DISLOCATIONS. 2 CASES OF REVISION TO TREAT A PELVIC RING FRACTURE WITH RECONSTRUCTION. RADIOGRAPHIC STUDY RESULTS: SEVERAL CASES OF PROGRESSIVE OSTEOLYSIS IDENTIFIED IN SERIAL RADIOGRAPHIC STUDIES- NO TREATMENT PROVIDED. UNKNOWN NUMBER OF MIGRATED FEMORAL STEMS IDENTIFIED ON SERIAL RADIOGRAPHIC STUDIES- NO TREATMENT PROVIDED. UNKNOWN NUMBER OF ACETABULAR SUBSIDENCE IDENTIFIED ON SERIAL RADIOGRAPHIC STUDIES-NO TREATMENT PROVIDED. CAPTURED IN THIS COMPLAINT: CASE 44 REVISED FOR INFECTION AND LOOSENING OF THE CUP AND STEM CUP AND STEM: PERIPROSTHETIC FRACTURE HEAD AND LINER: JOINT DISLOCATION POLYETHYLENE CUP: OSTEOLYSIS, IMPLANT MIGRATION FEMORAL STEM: IMPLANT MIGRATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415155 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1