BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S FEMORAL STEMS

    MDR report key: 22156485 · Received June 6, 2025

    Report

    Report Number
    3005180920-2025-00501
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802201
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2025 LOT 091868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2009. EXPIRATION DATE: 2014-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: IMPLANTS FROM CERAMTEC 38.39.7175.245.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (USA) (K073337) LOT 091990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2009. EXPIRATION DATE: 2014-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP 01.26.48MB VERSAFITCUP METALBACK DM Ø48 MM (K083116) LOT 090241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2009. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT 090253: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 27-APR-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT 15 YEARS 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON PLANS ON REVISING ALL IMPLANTS. A REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479684 QUADRA S FEMORAL STEMS STEM: QUADRA-S 01.12.03SN CEMENTLESS, SAND BLASTED STD STEM SIZE 3, SHORT NECK JDI MEDACTA INTERNATIONAL SA 01.12.03SN 091868 07630030802201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention