MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12; KNEE TIBIAL INSERT

Model Number	02.12.0312FR
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2020: lot 187251: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-12-05.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.Clinical evaluation performed by medacta medical affairs manager: secondary patella resurfacing and insert exchange performed 9 months after primary total knee arthroplasty due to pain and instability.This was caused by intervened arthritis of the patello-femoral joint.The insert was exchanged to a thicker one.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.This is not a problem due to any implant defect or malfunction.
Event or Problem Description
Due to pain and instability the patient was operated to change the inlay and to resurface the patella, 8 months after primary surgery.The patella implanted was from competitor, inlay changed from 12mm to 14mm.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10475976
• Report Number: 3005180920-2020-00555
• Device Sequence Number: 16833603
• Product Code: JWH
• UDI-Device Identifier: 07630030826382
• UDI-Public: 07630030826382
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 12/05/2023
• Device Model Number: 02.12.0312FR
• Device Catalogue Number: 02.12.0312FR
• Device Lot Number: 187251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/01/2020
• 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