MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM; KNEE FIXED TIBIAL INSERT

Model Number	02.07.0217SCF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2021: lot 131096: (b)(4) items manufactured and released on 20-mar-2013.Expiration date: 2018-01-31.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 since 1-jan-2017.
Event or Problem Description
The patient had a primary knee surgery and was implanted with competitor implants.On (b)(6) 2016, the patent had the competitor implants revised to medacta implants and the cause of the revision is unknown.4 years and 9 months after medacta primary the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert semiconstrained 17mm s2 with an insert semiconstrained 20mm s2 to give the patient more stability.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11663193
• Report Number: 3005180920-2021-00302
• Device Sequence Number: 19578281
• Product Code: JWH
• UDI-Device Identifier: 07630030816833
• UDI-Public: 07630030816833
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 01/31/2018
• Device Model Number: 02.07.0217SCF
• Device Catalogue Number: 02.07.0217SCF
• Device Lot Number: 131096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/14/2021
• 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
• Patient Age: 77 YR