BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 9122616 · Received September 26, 2019

    Report

    Report Number
    3005180920-2019-00809
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    August 28, 2019
    Report Date
    December 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAS BEEN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. NUMEROUS LABS HAVE BEEN TAKEN AND THE SURGEON, ABOUT 2 YEARS AFTER PRIMARY DECIDED TO EXPLANT ALL HARDWARE AND IMPLANT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. WHEN THE AGENT WAS ASKED IF THIS WAS AN INFECTION, SHE REPLIED THAT THE SURGEON IS NOT SURE WHAT THE ISSUE IS BUT DECIDED TO REMOVE ALL HARDWARE AND TAKE LABS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 SEPTEMBER 2019 LOT 166635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2017. EXPIRATION DATE: 2022-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 SEPTEMBER 2019 STEM: AMISTEM H 01.18.141 HA COATED LAT STEM SIZE 1 (K093944) LOT. 161434 LOT 161434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2016. EXPIRATION DATE: 2021-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2848 MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 171727 LOT 171727: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2017. EXPIRATION DATE: 2022-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 171403. LOT 171403: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2017. EXPIRATION DATE: 2022-07-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE REVISION SURGERY WILL TAKE PLACE ON (B)(6) 2019. MORE DETAILS TO FOLLOW ONCE THE REVISION SURGERY HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920369 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 166635 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention