MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

Catalog Number	02.07.0217SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2019: lot 146760: (b)(4) items manufactured and released on 27-oct-2017.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 other similar reported events.Clinical evaluation performed by medical affairs manager: delayed infection in hinged total knee arthroplasty, 2 years after implantation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other implants involved in the event, batch review performed on 18 july 2019.Gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721) lot.164179 lot 164179: (b)(4) items manufactured and released on 04-oct-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 other similar reported event.Gmk-revision 02.07.0003 offset connector 3 mm (k102437) lot.165116.Lot 165116: (b)(4) items manufactured and released on 11-nov-2016.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 other similar reported event.Gmk-revision 02.07.Fsc13065 extension stem - cemented ø 13 l 65 (k120790) lot.168992 lot 168992: (b)(4) items manufactured and released on 11-apr-2017.Expiration date: 2022-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.09.Ta210 tibial augmentation size 2/10mm (k130299) lot.142998 lot 142998: (b)(4) items manufactured and released on 12-jun-2014.Expiration date: 2019-04-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.09.Ta210 tibial augmentation sze 2/10mm (k1302999 lot.146735 lot 146735: (b)(4) items manufactured and released on 12-nov-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 other similar reported event.
Event or Problem Description
The patient had tibial loosening that was caused by an infection.The surgeon performed a revision of the implant 1 year and 10 months and a half after primary.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8844856
• Report Number: 3005180920-2019-00659
• Device Sequence Number: 16215880
• Product Code: JWH
• UDI-Device Identifier: 07630030816833
• UDI-Public: 07630030816833
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/31/2019

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: 09/30/2019
• Device Catalogue Number: 02.07.0217SCF
• Device Lot Number: 146760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/31/2019
• 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: 64 YR
• Patient Weight: 80