MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED # 3 / 14 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0314FUC
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 october 2019: lot 133334: (b)(4) items manufactured and released on 25-sep-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with similar reported event.Clinical evaluation performed by medical affairs manager: insert revision in tka 2 years and 10 months after primary for joint instability.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
Revision surgery performed 2 years and 8 months after the primary due to instability.The cause of the instability is unknown.The surgeon revised insert 14mm with insert 20mm.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED # 3 / 14 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9249738
• Report Number: 3005180920-2019-00913
• Device Sequence Number: 1864923
• Product Code: JWH
• UDI-Device Identifier: 07630030817236
• UDI-Public: 07630030817236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 02.07.0314FUC
• Device Lot Number: 133334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/29/2019
• 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