MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK FIXED TIBIAL INSERT; FIXED PE TIBIAL INSERT

Catalog Number	02.07.0312SF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 22 dec 2017 the medical affairs director made the following analysis: insert revision in tka 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.Batch review performed on 02 january 2018: (b)(4).
Event or Problem Description
The patient came in complaining of instability.The cause of instability is unknown.The surgeon revised the liner from a 12 mm to a 17 mm.The surgery was completed successfully.

• Brand Name: GMK FIXED TIBIAL INSERT
• Common Device Name: FIXED PE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163358
• Report Number: 3005180920-2017-00807
• Device Sequence Number: 63786
• Product Code: JWH
• UDI-Device Identifier: 07630030817182
• UDI-Public: 07630030817182
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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: 08/31/2019
• Device Catalogue Number: 02.07.0312SF
• Device Lot Number: 142816
• 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: 12/05/2017
• Initial Report FDA Received Date: 01/04/2018
• 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
• Patient Age: 72 YR