MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 1/12MM; KNEE TIBIAL INSERT SEMICONSTRAINED

Model Number	02.07.0112SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2020: lot 177653: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-01-11.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting instability due to laxity.The cause of the laxity is unknown.10 months after primary surgery, the surgeon revised the medacta insert semiconstrained 12mm s1 with a medacta insert semiconstrained 17mm s1.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 1/12MM
• Common Device Name: KNEE TIBIAL INSERT SEMICONSTRAINED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9726775
• Report Number: 3005180920-2020-00067
• Device Sequence Number: 11387907
• Product Code: JWH
• UDI-Device Identifier: 07630030816017
• UDI-Public: 07630030816017
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 01/11/2023
• Device Model Number: 02.07.0112SCF
• Device Catalogue Number: 02.07.0112SCF
• Device Lot Number: 177653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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