BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø 36/G

    MDR report key: 5621091 · Received April 29, 2016

    Report

    Report Number
    3005180920-2016-00171
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    March 22, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 21 JUNE 2016 AND INCLUDES: THE REVISION TOOK PLACE ON (B)(6) 2016. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 05 JULY 2016 AND INCLUDES: NO X-RAYS AND PIECES ARE AVAILABLE. ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 APRIL 2016. LOT 122760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 NOVEMBER 2012. EXPIRATION DATE: 2017-09-30. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4, CODE 01.29.208, LOT. 151161 (K112115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 APRIL 2015. EXPIRATION DATE: 2020-03-31. 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. CONCERNING LOT 151161, ON 18 APRIL 2016 THE CERAMIC MANUFACTURER FURTHER CONFIRMS THAT "THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT". DEVICE NOT YET EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT IS EXPERIENCING PAIN WHEN HE RUNS. THE PATIENT WOULD LIKE A REVISION TO REDUCE THE PAIN WHEN HE RUNS. THE DATE OF THE REVISION HAS NOT BEEN PLANNED, BUT IS EXPECTED TO BE IN (B)(6) OF 2016. X-RAYS WILL NOT BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275472 MPACT FLAT PE HC LINER Ø 36/G ACETABULAR FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 122760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention