BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL CC Ø 56

    MDR report key: 8883098 · Received August 12, 2019

    Report

    Report Number
    3005180920-2019-00679
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808173
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JULY 2019: LOT 180129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2018. EXPIRATION DATE: 2023-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 162715. BATCH REVIEW PERFORMED ON 18 JULY 2019: LOT 162715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2016. EXPIRATION DATE: 2021-07-20. 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 IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 (K092265) LOT. 183113. BATCH REVIEW PERFORMED ON 18 JULY 2019: LOT 183113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: QUADRA-H 01.12.036 CEMENTLESS, HA COATED LAT STEM # 6 (K082792) LOT. 070490A. BATCH REVIEW PERFORMED ON 18 JULY 2019: LOT 070490A: (B)(4) ITEM MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 2023-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INFECTED HIP 6 WEEKS POST OP. SURGEON HAS EXPLANTED PROSTHESIS TO TREAT INFECTION WITH ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679699 VERSAFITCUP ACETABULAR SHELL CC Ø 56 ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 180129 07630030808173

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention