BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 5520419 · Received March 23, 2016

    Report

    Report Number
    3005180920-2016-00109
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 22, 2016
    Report Date
    July 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 03 MARCH 2016 AND INCLUDES: THE INFECTION WAS CONFIRMED BUT THE SALES AGENT WAS NOT GIVEN THE RESULTS. ON (B)(4) 2016, THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: REVISION OF THA LESS THAN 2 YEARS SINCE FIRST OPERATION. ACCORDING TO REPORT, THERE WERE SIGNS OF INFECTION, NO CONFIRMATION IS AVAILABLE. CUP POSITION IS SUBOPTIMAL, BUT THERE IS NO INDICATION THAT THIS MAY HAVE CONTRIBUTED TO THE REVISION NEED. NO REASON TO SUSPECT THAT A FAULTY DEVICE ORIGINATED THE PROBLEM. BATCH REVIEW PERFORMED ON 21 MARCH 2016. LOT 135423: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.29.209, LOT. 130325 (K112115), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2013. EXPIRATION DATE: 2018-03-31. 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. MPACT ACETABULAR SHELL Ø 58 MULTI-HOLE, CODE 01.32.058MH, LOT. 115400 (K122641), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 AUGUST 2012. EXPIRATION DATE: 2017-07-31. 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 Ø 36/G, CODE 01.32.3652HCT, LOT. 122760 (K103721), (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. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 16 MAY 2016 AND INCLUDES: ON (B)(6) 2016, 4 MEDACTA CANCELLOUS BONE SCREWS WERE ALSO EXPLANTED. ON (B)(6) 2016 THE SURGEON REVISED THE HIP AND IMPLANTED A MEDACTA HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 10 JULY 2016 AND INCLUDES: THE PATHOGEN REPORT SHOWS THE INFECTION WAS NOT CONFIRMED, THE PATIENT HAD A CHRONIC INFLAMMATION. BATCH REVIEWS PERFORMED ON 13 JUNE 2016. CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25, CODE 01.32.6525, LOT. 115664 (K103721). A (B)(4) ITEMS OF THE SAME LOT INVOLVED IN THIS COMPLAINT. THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 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. 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. CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35, CODE 01.32.6535, LOT. 115666 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 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 AND 2 OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THIS LOT (MDRS 2015-00355 AND 2016-00303). ON 20 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH SIGNS OF AN INFECTION. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EXPLANTS WILL NOT BE RETURNED TO MEDACTA (B)(4). X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175556 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 135423

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention