MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3/12 MM; TIBIAL INSERT STANDARD

Model Number	02.07.0312SF
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020: lot 081216: (b)(4) items manufactured and released on 18-jul-2008.Expiration date: 2013-05-31.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 2016.Additional item involved in the event: gmk-primary 02.07.0034rp patella resurfacing size 2 (k090988) lot.113369.Batch review performed on 27 november 2020: lot 113369: (b)(4) items manufactured and released on 15-nov-2011.Expiration date: 2016-10-31.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 2016.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2012.On (b)(6) 2013, the patient came in for reasons unknown and had the tibial insert std fix s.3 / 12 mm revised to a tibial insert std fix s.3 / 10 mm.The surgery was completed successfully.On (b)(6) 2020 the revised the patient knee due to pain due to a loose patella implant and instability.The surgeon revised the patella and the tibial insert std fix s.3 / 10 mm with a insert u.C.12mm s3.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3/12 MM
• Common Device Name: TIBIAL INSERT STANDARD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10983850
• Report Number: 3005180920-2020-00895
• Device Sequence Number: 2975337
• Product Code: JWH
• UDI-Device Identifier: 07630030817182
• UDI-Public: 07630030817182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 05/31/2013
• Device Model Number: 02.07.0312SF
• Device Catalogue Number: 02.07.0312SF
• Device Lot Number: 081216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/10/2020
• 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