MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM

Model Number	02.07.0310SF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 24 september 2021: lot 133263: 60 items manufactured and released on 16-oct-2013.Expiration date: 2018-sep-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Clinical evaluation: insert revision in tka 5 years and 9 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
The patient came in reporting instability and the cause of the pain instability is unknown.About 5 years and 9 months after the primary surgery, the surgeon revised the insert std.10mm s3 with an insert u.C.14mm s3.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12665545
• Report Number: 3005180920-2021-00811
• Device Sequence Number: 11820494
• Product Code: JWH
• UDI-Device Identifier: 07630030817083
• UDI-Public: 07630030817083
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 09/30/2018
• Device Model Number: 02.07.0310SF
• Device Catalogue Number: 02.07.0310SF
• Device Lot Number: 133263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/20/2021
• 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