BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø 52 TWO-HOLES

    MDR report key: 5798385 · Received July 15, 2016

    Report

    Report Number
    3005180920-2016-00359
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 15, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 29 JUNE 2016 AND INCLUDES: NO PATHOGEN AVAILABLE. BATCH REVIEWS PERFORMED ON 14 JULY 2016. LOT 132795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2013. EXPIRATION DATE: 2018-09-30. 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. MPACT FLAT PE HC LINER Ø 36/E, CODE 01.32.3644HCT, LOT. 148748 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2015. EXPIRATION DATE: 2020-02-29. 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 H, HA COATED STEM SIZE 1 STD, CODE 01.18.131, LOT. 140004 (K093944) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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. COCR BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.25.031, LOT. 147314 (K080885) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40, CODE 01.32.6540, LOT. 115667 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2011. EXPIRATION DATE: 2017-03-31. 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 (MDR 2016-00175). MPACT SHELL SCREW PLUG, CODE 01.31.55TP, LOT. 153709 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2015. EXPIRATION DATE: 2020-04-30. 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 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30, CODE 01.32.6530, LOT. 115665 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 MARCH 2012. EXPIRATION DATE: 2017-02-28. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL THE PRIMARY IMPLANTS AND PLACED IN AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452319 MPACT ACETABULAR SHELL Ø 52 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 132795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention