MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0511FR
Health Effect - Clinical Codes	Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 12.08.2020: lot 180413: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came into the clinic after 8 months.He is a truckdriver and it is not possible for him to get the perfect flexion in the knee.He can`t reach 90° and he has patella pain.The patella is very thick regarding (the patient has arthrolyse).The surgeon wants to implant a patella and perhaps to revise the inlay from 11mm to 10 mm.The surgery is planned on (b)(6) 2020.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10464588
• Report Number: 3005180920-2020-00562
• Device Sequence Number: 2925377
• Product Code: JWH
• UDI-Device Identifier: 07630030862663
• UDI-Public: 07630030862663
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: 05/02/2023
• Device Model Number: 02.12.0511FR
• Device Catalogue Number: 02.12.0511FR
• Device Lot Number: 180413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/28/2020
• 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