MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM; KNEE TIBIAL INSERT

Model Number	02.07.0617SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-mar-2020: lot 156523: (b)(4) items manufactured and released on 23-nov-2015.Expiration date: 25.10.2020.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 since 2016.
Event or Problem Description
The patient had a primary knee surgery and was implanted with all competitors components.On (b)(6) 2017, the patient came in reporting pain and the surgeon revised all the competitor components (except the patella) implanting medacta components.Presently, on (b)(6) 2020 (3 years and 2 months after primary), the patient came in reporting instability.X-rays indicated that the prosthetic competitor patella implant dislocated from the natural patella bone.The surgeon revised the competitor patella with a medacta patella resurfacing s2 and revised the medacta insert semiconstrained 17mm s6 with a medacta insert semiconstrained 23mm s6.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9932417
• Report Number: 3005180920-2020-00227
• Device Sequence Number: 2628809
• Product Code: JWH
• UDI-Device Identifier: 07630030819155
• UDI-Public: 07630030819155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: 02.07.0617SCF
• Device Catalogue Number: 02.07.0617SCF
• Device Lot Number: 156523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/07/2020
• 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