MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM

Model Number	02.07.0512PSF
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-feb-2020.Lot 134313: (b)(4) items manufactured and released on 12-aug-2013.Expiration date: 31.10.2018.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2013.Clinical evaluation performed by medical affairs manager.Secondary patella resurfacing performed 4 years after primary total knee arthroplasty due to pain in a (b)(6) man.This was caused by intervened arthritis of the patello-femoral joint.During this operation, as customary, the tibial insert has been changed to a new one, but no problem or defect originated this replacement.
Event or Problem Description
Revision surgery performed due to anterior knee pain, 4 years after primary.The inlay has been changed with 14 mm inlay and patella resurfacing has been performed.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9693399
• Report Number: 3005180920-2020-00040
• Device Sequence Number: 1742371
• Product Code: JWH
• UDI-Device Identifier: 07630030818325
• UDI-Public: 07630030818325
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 10/31/2018
• Device Model Number: 02.07.0512PSF
• Device Catalogue Number: 02.07.0512PSF
• Device Lot Number: 134313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: 67 YR
• Patient Weight: 120