MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

Catalog Number	02.07.0417SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 september 2019: lot 162518: (b)(4) items manufactured and released on "22-ago-2016".Expiration date: 2021-07-26.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.Other devices involved in the complaint.Gmk-revision 02.07.0684r revision fixed tibial tray cemented size 4 r lot.164180 (k123721).Batch review performed on 2 september 2019: lot 164180: (b)(4) items manufactured and released on 25-sep-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 with another similar event reported.Gmk-revision 02.07.2405r femur revision ps size 5 r lot.171336 (k102437).Batch review performed on 2 september 2019: lot 171336: (b)(4) items manufactured and released on 14-jun-2017.Expiration date: 2022-05-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar event reported.Gmk-revision 02.07.Fcl18105 extension stem - fluted ø 18 l 105 lot.172187 (k120790).Batch review performed on 2 september 2019: lot 172187: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-07-02.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 02.07.0003 offset connector 3 mm lot.178518 (k102437).Batch review performed on 2 september 2019: lot 178518: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-02-27.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 02.07.Fcl13105 extension stem - fluted ø 13 l 105 lot.160040 (k120790).Batch review performed on 2 september 2019: lot 160040: (b)(4) items manufactured and released on 08-apr-2016.Expiration date: 2021-03-29.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 02.09.Ta410 tibial augmentation size 4/10mm lot.123246b (k130299).Batch review performed on 2 september 2019: lot 123246b: (b)(4) items manufactured and released on 09-apr-2018.Expiration date: 2023-03-25.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.2 devices of this lot involved in this complaint.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.The patient came in due to signs of infection and the pathogen was unknown.The surgeon subsequently performed an i&d and poly swap on (b)(6) 2019 and complaint (b)(4) was filed.Presently 9 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9086485
• Report Number: 3005180920-2019-00782
• Device Sequence Number: 2614863
• Product Code: JWH
• UDI-Device Identifier: 07630030817991
• UDI-Public: 07630030817991
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 07/26/2021
• Device Catalogue Number: 02.07.0417SCF
• Device Lot Number: 162518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: 81 YR