BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 6180748 · Received December 16, 2016

    Report

    Report Number
    3005180920-2016-00670
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 16, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY THE PATIENT HAD A PRIMARY IN (B)(6) 2012. THE PATIENT CAME IN FOR A REVISION IN (B)(6) 2012. THE REASON FOR THE REVISION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS SUCCESSFUL. IN (B)(6) 2016 THE PATIENT CAME IN COMPLAINING OF HIP PAIN. ADDITIONAL INFORMATION RECEIVED ON 25 NOVEMBER 2016 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 30 NOVEMBER 2016 AND INCLUDES: THE REASON OF PAIN STILL REMAINED UNKNOWN. BATCH REVIEWS PERFORMED ON 13 DECEMBER 2016. LOT 101759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JANUARY 2011. EXPIRATION DATE: 2015-12-31. 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 FLAT PE HC LINER Ø36/F, CODE 01.32.3648HCT, LOT. 121154 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 JULY 2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 36 SIZE XXL +10.5, CODE 01.25.034, LOT. 081613 (K080885) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2008. EXPIRATION DATE: 2013-08-31. 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 45, CODE 01.32.6545, LOT. 103030 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JANUARY 2011. EXPIRATION DATE: 2015-12-31. 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 30, CODE 01.32.6530, LOT. 103027 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2011. EXPIRATION DATE: 2015-12-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF HIP PAIN. THE CAUSE OF PAIN IS UNKNOWN AT THIS TIME. THE SURGEON PLANS TO REVISE THE HEAD AND LINER AND THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831365 MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 101759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention