MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.2213L FEMUR CEMENTED PS SIZE 3 NARROW / LEFT; KNEE FEMUR CEMENTED

Model Number	02.07.2213L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to loose femur and tibial components.About 8 years and 3 months after the primary surgery, the surgeon revised all components to revision components.Components came out with no adherent cement on the back of the components.Very clean components.Cement stayed on the bone.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 october 2022 lot 140918: (b)(4) items manufactured and released on 03-apr-2014.Expiration date: 2019-feb-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Other device involved: gmk-primary 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 140183: (b)(4) items manufactured and released on 18-mar-2014.Expiration date: 2019-feb-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-PRIMARY 02.07.2213L FEMUR CEMENTED PS SIZE 3 NARROW / LEFT
• Common Device Name: KNEE FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15860752
• Report Number: 3005180920-2022-00856
• Device Sequence Number: 5981601
• Product Code: JWH
• UDI-Device Identifier: 07630030820960
• UDI-Public: 07630030820960
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 11/24/2022

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: 02/28/2019
• Device Model Number: 02.07.2213L
• Device Catalogue Number: 02.07.2213L
• Device Lot Number: 140918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2014
• 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: Female