MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.0512SF TIBIAL INSERT STD FIXED SIZE 5 / 12 MM; KNEE TIBIAL INSERT STD FIXED

Model Number	02.07.0512SF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 years and 1 month after the primary surgery, the patient came in reporting instability due to laxity.The surgeon revised the insert std.12mm s5 with a thicker one (insert u.C.14mm s5) to give the patient more stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 114154: 50 items manufactured and released on 09-feb-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs director: 6 years after cemented primary tka the patient develops instability, probably due to developmental ligament insufficiency, and a change of insert is required.A thicker inlay with a more intrinsically stable design is implanted.The metal components were deemed to be strongly fixed and well positioned and therefore left in place.This reintervention is due to disease progression and definitely not to a device deficiency.

• Brand Name: GMK-PRIMARY 02.07.0512SF TIBIAL INSERT STD FIXED SIZE 5 / 12 MM
• Common Device Name: KNEE TIBIAL INSERT STD FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15001037
• Report Number: 3005180920-2022-00520
• Device Sequence Number: 13852160
• Product Code: JWH
• UDI-Device Identifier: 07630030818349
• UDI-Public: 07630030818349
• 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: 2022
• 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): 07/13/2022

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: 12/31/2016
• Device Model Number: 02.07.0512SF
• Device Catalogue Number: 02.07.0512SF
• Device Lot Number: 114154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male