MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.2205L FEMUR PS CEMENTED SIZE 5 L; FEMUR CEMENTED

Model Number	02.07.2205L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of all components (tibia, inlay, femur, except patella resurfacing) 4 years after the primary surgery implant due to instability.
Additional Manufacturer Narrative
Batch review performed on 18 january 2022.Lot 147849: (b)(4) items manufactured and released on (b)(6) 2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: knee revision surgery performed 4 years after cemented tka in a (b)(6) man.According to the report, the reason for revision is knee instability.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.This is not a problem due to any implant defect or malfunction.Additional implant involved: batch review performed on 18 january 2022.Gmk-primary 02.07.0510psf tibial insert ps fixed # 5/10mm (k090988), lot 170479: (b)(4) items manufactured and released on 17-may-2017.Expiration date: 2023-may-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Gmk-primary 02.07.1205l tibial tray fixed cemented # 5 l (k090988) lot 171947: (b)(4) items manufactured and released on 15-sep-2017.Expiration date: 2022-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: GMK-PRIMARY 02.07.2205L FEMUR PS CEMENTED SIZE 5 L
• Common Device Name: FEMUR CEMENTED
• 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: 13506095
• Report Number: 3005180920-2022-00093
• Device Sequence Number: 20112548
• Product Code: JWH
• UDI-Device Identifier: 07630030820861
• UDI-Public: 07630030820861
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 01/31/2020
• Device Model Number: 02.07.2205L
• Device Catalogue Number: 02.07.2205L
• Device Lot Number: 147849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2015
• 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 Age: 59 YR
• Patient Sex: Male