MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 4 R; KNEE FEMORAL COMPONENT

Model Number	02.07.2404R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2019: lot 135884: 15 items manufactured and released on 11-dec-2013.Expiration date: 2018-oct-31.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.1204r fixed tibial tray cemented size 4 r (k090988) lot.136136.Batch review performed on 14 november 2019: lot 136136: 32 items manufactured and released on 11-mar-2014.Expiration date: 2019-jan-31.No anomalies found related to the problem.To date, 31 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.0412scf fixed tibial insert sc size 4/12mm (k103170) lot.121807.Batch review performed on 14 november 2019: lot 121807: 25 items manufactured and released on 02-may-2012.Expiration date: 2017-mar-31.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold with another similar event reported.Additional implant involved: gmk-revision 02.07.0035rp patella resurfacing size 3 (k090988) lot.136083 batch review performed on 14 november 2019: lot 136083: 240items manufactured and released on 07-feb-2014.Expiration date: 2018-dec-31.No anomalies found related to the problem.To date, 239 items of the same lot have been already sold with another similar event reported.Additional implant involved: gmk-revision 02.07.Fcl15150 extension stem - fluted ø 15 l 150 (k120790) lot.115719.Batch review performed on 14 november 2019: lot 115719: 40 items manufactured and released on 24-ago-2012.Expiration date: 2017-june-30.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.Fcl13105 extension stem fluted ø 13 l 105 (k120790) lot.131538.Batch review performed on 14 november 2019: lot 131538: 15 items manufactured and released on 08-may-2013.Expiration date: 2018-mar-31.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 5 years after medacta implant insertion the surgeon revised the patient knee for infection.The surgery was completed successfully.
Additional Manufacturer Narrative
On the (b)(6) 2020, we were informed that the patient had permanent hardware implanted on the (b)(6) 2020.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 4 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9382049
• Report Number: 3005180920-2019-01010
• Device Sequence Number: 2055868
• Product Code: JWH
• UDI-Device Identifier: 07630030821431
• UDI-Public: 07630030821431
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 10/31/2018
• Device Model Number: 02.07.2404R
• Device Catalogue Number: 02.07.2404R
• Device Lot Number: 135884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 04/07/2020
• 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