MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM

Catalog Number	02.07.0110PSF
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2019: lot 173724: 30 items manufactured and released on 25-july-17.Expiration date: 2022-07-04.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on 13 november 2019.Gmk-primary 02.07.0681l revision fixed tibial tray cemented size 1 l (k123721) lot.186391 lot 186391: 22 items manufactured and released on 07-aug-18.Expiration date: 2023-07-26.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-primary 02.07.F11030 primary extension stem ø11mm / l 30 mm lot.182980 lot 182980: 150 items manufactured and released on 17-luly-18.Expiration date: 2023-06-25.No anomalies found related to the problem.To date, 144 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed 1 year after the primary due to pain caused by a severe flexion contraction.The cause of the severe flexion contraction is unknown.The surgeon revised the tibial tray, insert, and stem.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9390198
• Report Number: 3005180920-2019-01003
• Device Sequence Number: 2490708
• Product Code: JWH
• UDI-Device Identifier: 07630030815904
• UDI-Public: 07630030815904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2019

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: 07/04/2022
• Device Catalogue Number: 02.07.0110PSF
• Device Lot Number: 173724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/28/2019
• 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