MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY UC INSERT; TIBIAL PE UC LINER

Catalog Number	02.07.0212FUC
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 11 november 2017: the patient was instable for years.On 22 dec 2017 the medical affairs made the following analysis: insert revision in tka 3 years and 7 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.On 02 jan 2018 the r&d project manager made the following comments: from the pictures in our hand, it is not possible to properly determine if the insert is dimensionally in compliance with the specification, damaged or plastically deformed.Batch review performed on 02 january 2018: lot 130891: (b)(4) items manufactured and released on 11 april 2013.Expiration date: 2018-02-28 no anomalies found related to the issue.To date, (b)(4)items of the same lot have been already sold with 1 similar reported event.
Event or Problem Description
The patient came in complaining of instability.The cause of instability is unknown.The surgeon revised the liner from a 12mm to a 20mm.The surgery was completed successfully.

• Brand Name: GMK PRIMARY UC INSERT
• Common Device Name: TIBIAL PE UC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7160294
• Report Number: 3005180920-2017-00801
• Device Sequence Number: 13814762
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: 02/28/2018
• Device Catalogue Number: 02.07.0212FUC
• Device Lot Number: 130891
• 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: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• 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