MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM

Model Number	02.07.0412PSF
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2021: lot 173732: (b)(4) items manufactured and released on 26-jul-2017.Expiration date: 2022-07-11.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.
Event or Problem Description
The patient had a primary surgery and was implanted with competitor implants.On (b)(6) 2021, the patient had the competitor implants revised to medacta implants for reasons unknown.Presently, on (b)(6) 2021, the patient came in reporting pain due to a torn patella tendon.The cause of the torn patella tendon is unknown.The surgeon repaired the patella tendon and revised the insert p.S.12mm s4 with a insert semiconstrained 12mm s4.The surgery was completed successfully.

• Brand Name: GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11640108
• Report Number: 3005180920-2021-00277
• Device Sequence Number: 2987902
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• 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: 2021
• Device Explanted Year: 2021
• 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): 04/09/2021

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: 07/11/2022
• Device Model Number: 02.07.0412PSF
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 173732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/09/2021
• 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