BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    MDR report key: 13826438 · Received March 19, 2022

    Report

    Report Number
    3005180920-2022-00181
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 FEBRUARY 2022. LOT 2012905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-03-25. 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 18 FEBRUARY 2022: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 2103099: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2021. EXPIRATION DATE: 2026-04-18. 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. STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM # 3 (K082792) LOT 182834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2018. EXPIRATION DATE: 2023-09-05. 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. CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL Ø 52 (K083116) LOT 188841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531031 BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 2012905 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention