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

Model Number	02.12.0312FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2020.Lot#: 163070: (b)(4) items manufactured and released on 04-aug-2016.Expiration date: 2021-07-21.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 medical affairs manager: insert revision and patella resurfacing in tka 3 years and 10 months after primary for joint instability and pain.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.A secondary patellar resurfacing should not be considered a failure: sometimes surgeons prefer to postpone patella arthroplasty in order to preserve maximum quantity of bone and reduce trauma, and proceed to treat only in case of persistent anterior pain.This is not a problem due to any implant defect or malfunction.
Event or Problem Description
The patient had pain and the knee wasn't stable, therefore, the surgeon decided to change to a thicker inlay and put a patella (3 years and 10 months after primary surgery).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11025983
• Report Number: 3005180920-2020-00906
• Device Sequence Number: 668602
• 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: 2017
• 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): 12/17/2020

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: 07/21/2021
• Device Model Number: 02.12.0312FR
• Device Catalogue Number: 02.12.0312FR
• Device Lot Number: 163070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/17/2020
• 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
• Patient Weight: 111