MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 12 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0212FUC
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 10 october 2019.Lot 131899: 30 items manufactured and released on 2-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager.Insert revision in tka more than 5 years 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
The patient came in, 5 years and 8 months after primary surgery, complaining of instability and the cause of instability is unknown.The surgeon revised the medacta tibial insert u.C.Fix s.2 / 12 mm with a medacta insert u.C.17mm s2.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2019 the surgeon performed the revision surgery of this patient and the entire prosthesis has been revised.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 12 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9255104
• Report Number: 3005180920-2019-00915
• Device Sequence Number: 2550286
• Product Code: JWH
• UDI-Device Identifier: 07630030816550
• UDI-Public: 07630030816550
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2019

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: 06/30/2018
• Device Catalogue Number: 02.07.0212FUC
• Device Lot Number: 131899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/28/2019
• 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