BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø 58 TWO-HOLES

    MDR report key: 6878299 · Received September 20, 2017

    Report

    Report Number
    3005180920-2017-00521
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    August 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 18 SEPTEMBER 2017. LOT 164345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 AUGUST 2016. EXPIRATION DATE: 2021-08-17. 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. AMISTEM COLLARED STEM, HA COATED STEM SIZE 7 STD, CODE 01.18.237, LOT. 153454 (K121011) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-23. 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 40 SIZE L + 4, CODE 01.29.214, LOT. 141174 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 JUNE 2014. EXPIRATION DATE: 2019-04-30. 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. MPACT FLAT PE HC LINER Ø40/F, CODE 01.32.4048HCT, LOT. 162090 (K122641) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JULY 2016. EXPIRATION DATE: 2021-06-12. 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. MPACT SHELL SCREW PLUG, CODE 01.31.55TP, LOT. 165385 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 AUGUST 2016. EXPIRATION DATE: 2021-07-26. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40, CODE 01.32.6540, LOT. 165279 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-22. 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 Manufacturer Narrative · 1

    ON (B)(6) 2017 IT WAS COMMUNICATED THE FOLLOWING: ON (B)(6) 2017 THE SPACER WAS REVISED AND THE FOLLOWING PERMANENT IMPLANTS WERE PUT INTO THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE. THE SURGEON IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660084 MPACT ACETABULAR SHELL Ø 58 TWO-HOLES CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 164345 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention