MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/14MM

Catalog Number	02.07.0214PSF
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-dec-2019.Lot 1904290: (b)(4) items manufactured and released on 15-jul-2019.Expiration date: 02.07.2024.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.Other devices involved in the event: gmk-primary 02.07.0214psf tibial insert ps fixed # 2/14mm lot.150810 (k090988).Batch review performed on 18-dec-2019.Lot 150810: (b)(4) items manufactured and released on 07-oct-2015.Expiration date: 20.09.2020.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-primary 02.07.1202r tibial tray fixed cemented # 2 r lot.1902697 (k090988).Batch review performed on 18-dec-2019.Lot 1902697: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 05.10.2024.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
During the primary knee surgery, when the surgeon was attempting to implant the insert p.S.14mm s2, it was observed that the poly would not seat.After 20 minutes, the agent opened up another insert p.S.14mm s2 poly to use.This poly would also not seat.20 minutes later, the agent opened a insert p.S.17mm s2 poly, and it seated.There was a 45-minute delay in the case and additional anaesthesia was used.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/14MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9523303
• Report Number: 3005180920-2019-01104
• Device Sequence Number: 10859948
• Product Code: JWH
• UDI-Device Identifier: 07630030816680
• UDI-Public: 07630030816680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: 07/02/2024
• Device Catalogue Number: 02.07.0214PSF
• Device Lot Number: 1904290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/27/2019
• 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: Other