MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC # 2/14MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0214SCF
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 september 2019: lot 185105: (b)(4) items manufactured and released on 4 septmeber 2018.Expiration date: 2023-08-22.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.
Event or Problem Description
Revision surgery performed 1 month after the primary due to pain caused by a superficial wound and draining distal to the wound.The surgeon performed a washout and poly swap successfully.Infection is not confirmed.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC # 2/14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9128547
• Report Number: 3005180920-2019-00816
• Device Sequence Number: 2591642
• Product Code: JWH
• UDI-Device Identifier: 07630030816710
• UDI-Public: 07630030816710
• 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): 09/27/2019

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: 08/22/2023
• Device Catalogue Number: 02.07.0214SCF
• Device Lot Number: 185105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/27/2019
• 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: Required Intervention