MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 5 R

Catalog Number	02.07.2405R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 may 2018; lot 162496: (b)(4) items manufactured and released on 25 may 2016.Expiration date:2021-05-05 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Others devices involved: gmk-revision reference 02.07.0412scf fixed tibial insert sc size 4/12mm; lot 165093: (b)(4) items manufactured and released on 12 october 2016.Expiration date:2021-09-27; 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 reference 02.07.0684r revision fixed tibial tray cemented size 4 r; lot 164180: (b)(4) items manufactured and released on 29 september 2016.Expiration date: 2021-09-20; 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 reference 02.07.Fcl22105 extension stem - fluted ø 22 l 105; lot 161797: (b)(4) items manufactured and released on 10 may 2016.Expiration date: 2021-04-25; 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 reference 02.05.05dw femoral wedge distal size 5/8mm; lot 162598: (b)(4) items manufactured and released on 30 june 2016.Expiration date: 2021-06-08.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 (2 pieces of this lot involved in this complaint).Gmk-revision reference 02.07.0003 offset connector 3 mm; lot 162576: 110 items manufactured and released on 26 july 2016.Expiration date: 2021-06-20 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event gmk-revision reference 02.09.Ta305 tibial augmentation size 3/5mm; lot 165138: (b)(4) items manufactured and released on 27 september 2016.Expiration date: 2021-09-01; 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 reference 02.07.Fcl20105 extension stem - fluted ø 20 l 105; lot 167145: (b)(4) items manufactured and released on 26 january 2017.Expiration date: 2022-01-18; 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
One year after primary the patient had a knee infection.The surgeon removed all the implants and inserted a spacer.Later, on the (b)(6) 2018 swapped the spacer with definitive implants.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 5 R
• Common Device Name: FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7486990
• Report Number: 3005180920-2018-00298
• Device Sequence Number: 19323530
• Product Code: JWH
• UDI-Device Identifier: 07630030821455
• UDI-Public: 07630030821455
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 05/05/2021
• Device Catalogue Number: 02.07.2405R
• Device Lot Number: 162496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/04/2018
• 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