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

Catalog Number	02.12.0312FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 148388: 58 items manufactured and released on 09/08/2015.Expiration date: 06/30/2020.No anomalies found related to the problem.To date, 50 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 2 years after primary the surgeon performed an arthroscopy and open synovectomy and decided to replace the 12mm tibial insert.The insert was replaced with a 13mm one at this time.The surgeon noted that the explanted insert was in good condition.As per verbal notification the reason of pain is unknown and there was no knee instability.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 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: 8914445
• Report Number: 3005180920-2019-00689
• Device Sequence Number: 13910645
• Product Code: JWH
• UDI-Device Identifier: 07630030826382
• UDI-Public: 07630030826382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

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: 06/30/2020
• Device Catalogue Number: 02.12.0312FR
• Device Lot Number: 148388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/21/2019
• 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: 68 YR