MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM; TIBIAL INSERT FIXED

Model Number	02.07.0412PSF
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 december 2020: lot 155118: (b)(4) items manufactured and released on 02-feb-2016.Expiration date: 2021-01-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 1-1-2016.
Event or Problem Description
Revision surgery planned for knee instability.The surgeon wants to swap the liner for a thicker one.
Event or Problem Description
Revision surgery performed due to knee instability.
Additional Manufacturer Narrative
On december 22nd 2020 we have received the following information: the revision date, place and surgeon have been confirmed.Only the liner has been revised, the new liner was 14 mm high the reason of the revision was instability.The explant and x-rays are nor available.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11046850
• Report Number: 3005180920-2020-00940
• Device Sequence Number: 2692443
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: 02.07.0412PSF
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 155118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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: Other; Required Intervention