MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.0682R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 173077: 16 items manufactured and released on 09/07/2017.Expiration date: 08/24/2022.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any other similar reported event.Additional devices involved: batch reviews performed on (b)(6) 2019: gmk-sphere 02.07.F11030 primary extension stem ø11mm / l 30 mm (k123721) lot 182015: 140 items manufactured and released on 05/08/2018.Expiration date: 04/23/2023.No anomalies found related to the problem.To date, 128 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.09.Ta210 tibial augmentation size 2/10mm (k123721) lot 157176: 18 items manufactured and released on 02/01/2016.Expiration date: 01/21/2021.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0214fr tibial insert fixed sphere flex size 2/14 mm r (k123721) lot 170317: 30 items manufactured and released on 05/09/2017.Expiration date: 04/22/2022.No anomalies found related to the problem.To date, 2 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k123721) lot 162681: 60 items manufactured and released on 06/092016.Expiration date: 05/22/2021.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k123721) lot 176302: 120 items manufactured and released on 01/05/2018.Expiration date: 12/13/2022.No anomalies found related to the problem.To date, 115 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.The patient subsequently had a revision surgery on (b)(6) 2019.The patient came in complaining of instability and the surgeon performed a poly-swap.Mdr 3005180920-2019-00047 was done.On (b)(6) 2019, the patient came in complaining of instability (1 year and 4 months after primary surgery) and medacta international was informed the same day.The surgeon on the (b)(6) 2019 revised the patient and performed a hinged knee arthroplasty.All hardware revised.The surgery was completed successfully.

• Brand Name: GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8914342
• Report Number: 3005180920-2019-00695
• Device Sequence Number: 617731
• Product Code: JWH
• UDI-Device Identifier: 07630030819353
• UDI-Public: 07630030819353
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/21/2019

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: 08/24/2022
• Device Catalogue Number: 02.07.0682R
• Device Lot Number: 173077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/21/2019
• 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