MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM

Catalog Number	02.07.0214FUC
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2018; lot 080861: (b)(4) items manufactured and released on 02 june 2008 expiration date: 2013-03-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs on 09 march 2018: insert revision in tka 7,5 years after primary for joint dislocation.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
The patient came in due to dislocation.The surgeon revised the 14mm insert with a 17mm insert.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM
• Common Device Name: TIBIAL INSERT UC FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7326624
• Report Number: 3005180920-2018-00128
• Device Sequence Number: 18859371
• Product Code: JWH
• UDI-Device Identifier: 07630030816659
• UDI-Public: 07630030816659
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 03/31/2013
• Device Catalogue Number: 02.07.0214FUC
• Device Lot Number: 080861
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/09/2018
• 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