MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM L

Model Number	02.12.0213FL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020 lot 178739: 30 items manufactured and released on 08-may-2018.Expiration date: 2023-04-17.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any similar reported event.Clinical evaluation two years after primary cemented tka, secondary instability develops and the pe liner is exchanged to a thicker one.This is disease progression and the second operation is therefore not related to a faulty device.
Event or Problem Description
Revision surgery performed due to 2 years and 1 month after the primary surgery.The 13mm gmk sphere poly liner was exchanged for a 20mm liner, as the patient has described a feeling of instability.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM L
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11030155
• Report Number: 3005180920-2020-00925
• Device Sequence Number: 19159402
• Product Code: JWH
• UDI-Device Identifier: 07630030862533
• UDI-Public: 07630030862533
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2023
• Device Model Number: 02.12.0213FL
• Device Catalogue Number: 02.12.0213FL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2020
• 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 Age: 69 YR
• Patient Weight: 72