BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD

    MDR report key: 5666931 · Received May 19, 2016

    Report

    Report Number
    3005180920-2016-00233
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 28, 2015
    Report Date
    July 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 JULY 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION BASED ON THE X-RAYS RECEIVED ON (B)(6) 2016, AND COMMENTED AS FOLLOWS: CEMENTLESS THA ON A FEMALE PATIENT OF (B)(6) WAS REVISED. FIBROTIC TISSUE WAS FOUND AT REVISION AND DUE TO THE APPEARANCE SENT FOR MICROBIOLOGICAL INVESTIGATION, BUT NO GROWTH WAS FOUND. IN THE POSTOPERATIVE RADIOGRAPH, THE CUP LOOKS SOMEWHAT OVERSIZED AND TOO HORIZONTALLY ORIENTED; THE FEMORAL RESECTION IS PROBABLY TOO LOW MEDIALLY, HENCE DIMINISHING THE BONE SUPPORT AVAILABLE FOR STEM STABILIZATION. LIMITED SIGNS OF OSTEOLYSIS, OR PERHAPS RADIOLUCENCY, AT FEMORAL LEVEL, AND WEAR OF THE PE INSERT IS NOT EVIDENT, ALTHOUGH IT IS TO BE EXPECTED IN A PATIENT OF (B)(6) WITH NO KNOWN COMORBIDITIES.

    Additional Manufacturer Narrative · 1

    ON 18 MAY 2016 MEDACTA INTERNATIONAL REQUESTED A BATCH REVIEW OF THE CERAMIC BALL HEAD INVOLVED IN THIS COMPLAINT AND MANUFACTURED BY (B)(4). BATCH REVIEWS PERFORMED ON 17 MAY 2016. LOT 092046: 69 ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2009. EXPIRATION DATE: 2014-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP ACETABULAR SHELL Ø 48, CODE 01.26.48MB, LOT. 092434 (K083116). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 DECEMBER 2009. EXPIRATION DATE: 2014-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DOUBLE MOBILITY LINER Ø 48/28, CODE 01.26.2848M, LOT. 092225 (K083116). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2009. EXPIRATION DATE: 2014-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON 27 MAY 2016 (B)(4) PROVIDED THE DOCUMENT REVIEW OF THE PRODUCT INVOLVED IN THIS COMPLAINT (CERAMIC BALL HEAD, NOT MARKETED IN USA) AND COMMENTED AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. DUE TO THE LACK OF CERAMIC PARTS, NO FURTHER INVESTIGATION COULD BE DONE.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN IN THE HIP. ON (B)(6) 2015 THE REVISION SURGERY TOOK PLACE. THE PATIENT RECEIVED SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322970 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 092046

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention