MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 12 MM; KNEE TIBIAL INSERT PE

Model Number	02.07.0512SF
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain after injuring their mcl and the cause is unknown.At 5 years and 6 months after primary the surgeon repaired the mcl and revised the insert.The surgery was completed successfully.Implanted insert: 02.07.0514fuc insert u.C.14mm s5 1904306.
Additional Manufacturer Narrative
Batch review performed on 07 april 2022: lot 133271: (b)(4) items manufactured and released on 29-july-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-1-2018.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 12 MM
• Common Device Name: KNEE TIBIAL INSERT PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14072306
• Report Number: 3005180920-2022-00258
• Device Sequence Number: 6137326
• Product Code: JWH
• UDI-Device Identifier: 07630030818349
• UDI-Public: 07630030818349
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 04/11/2022

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: 06/30/2018
• Device Model Number: 02.07.0512SF
• Device Catalogue Number: 02.07.0512SF
• Device Lot Number: 133271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown