MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 6 L

Catalog Number	02.07.2406L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 september 2018; lot 112689a: (b)(4) items manufactured and released on 07 october 2013.Expiration date: 08-31-2018; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Revision fixed tibial tray cemented size 5 l reference 02.07.0685l (k123721); lot 122881: (b)(4) items manufactured and released on 26 october 2012.Expiration date: 09.30.2017; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-revision offset connector 3 mm reference 02.07.0003 (k102437); lot 150580: (b)(4) items manufactured and released on 20 may 2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk revision offset connector 5 mm reference 02.07.0005 (k102437); lot 150581: (b)(4) items manufactured and released on 12 may 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.Gmk-revision extension stem - fluted ø 22 l 105 reference 02.07.Fcl22105 (k120790); lot 145064: (b)(4) items manufactured and released on 07 november 2014.Expiration date: 2019-09-30; 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.Gmk-revision femoral wedge posterior # 6/10mm reference 02.07.610fpw (k102437); lot 115115: (b)(4) items manufactured and released on 05 march 2012 expiration date: 2017-01-31 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.Gmk-revision fixed tibial insert sc size 5/14mm reference 02.07.0514scf (k103170); lot 125710: (b)(4) items manufactured and released on 21 february 2013.Expiration date: 2018-01-31; 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.Gmk-revision tibial augmentation size 5/5mm reference 02.09.Ta505 (k130299); lot 145124: (b)(4) items manufactured and released on 12 september 2014.Expiration date: 2019-07-31; 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.Gmk-revision tibial augmentation screwed s5 - 5 mm 02.09.Ta505 (k130299); lot 112183: (b)(4) items manufactured and released on 20 december 2015.Expiration date: 2021-10-30; 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.
Event or Problem Description
About 3 years and a half after primary for a relapse infection the surgeon completed the revision surgery explanting the spacer (implanted on an unknown date) and implanted the definitive devices.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 6 L
• Common Device Name: FEMUR REVISION PS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7850449
• Report Number: 3005180920-2018-00661
• Device Sequence Number: 16535778
• Product Code: JWH
• UDI-Device Identifier: 07630030821462
• UDI-Public: 07630030821462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 02.07.2406L
• Device Lot Number: 112689A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR