MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L; KNEE FIXED TIBIAL INSERT

Model Number	02.12.0212FL
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 february 2021: lot 140316: (b)(4) items manufactured and released on 19-feb-2014.Expiration date: 31-01-2019.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event since 2017.
Event or Problem Description
Patient reported worsening anterior knee pain and it was planned to resurface the patella bone with the implant.Patella was resurfaced after 6 years and 7 months from the primary surgery and liner was replaced with a 1mm larger liner due to some laxity.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11398277
• Report Number: 3005180920-2021-00159
• Device Sequence Number: 4568260
• Product Code: JWH
• UDI-Device Identifier: 07630030826177
• UDI-Public: 07630030826177
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 03/02/2021

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: 01/31/2019
• Device Model Number: 02.12.0212FL
• Device Catalogue Number: 02.12.0212FL
• Device Lot Number: 140316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/02/2021
• 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