MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/14 MM L; KNEE TIBIAL INSERT

Catalog Number	02.12.0614FL
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019: lot 120383: (b)(4) items manufactured and released on 27-apr-2012.Expiration date: 2017-03-31.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 director: 3 years after primary cemented tka the patient complains about anterior knee pain and the surgeon resurfaced the patella and applied a thicker insert.No information is of course yet available about the success of this treatment.Apparently, it's a case of disease progression and secondary instability and not caused by a deficiency in the implanted device performance.
Event or Problem Description
The patient had knee pain, the cause is unknown.About 3 years after primary the surgeon resurfaced the patella and revised the 14mm insert with a 20mm one.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/14 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8695290
• Report Number: 3005180920-2019-00459
• Device Sequence Number: 14014986
• Product Code: JWH
• UDI-Device Identifier: 07630030827013
• UDI-Public: 07630030827013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 06/13/2019

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: 03/31/2017
• Device Catalogue Number: 02.12.0614FL
• Device Lot Number: 120383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/13/2019
• 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