MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L; KNEE STANDARD FEMUR

Model Number	02.07.2004L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gmk-primary 02.07.2004l femur std cemented size 4 l lot.120962.Lot 120962: (b)(4) manufactured and released on 11-may-2012.Expiration date: 2017-03-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Additional items involved in the event, batch review performed on (b)(6) 2023.Gmk-primary 02.07.0035rp patella resurfacing size 3 (k090988) lot.121109.Lot 121109: (b)(4) manufactured and released on 23-may-2012.Expiration date: 2017-04-30.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Gmk-primary 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.121137.Lot 121137: (b)(4) manufactured and released on 30-may-2012.Expiration date: 2017-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 10 years and 5 months after primary, the patient came in reporting pain due to the loosening of femoral and patella implants and subsidence of tibial component.The cause is unknown.The surgeon revised to revision system and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L
• Common Device Name: KNEE STANDARD FEMUR
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17215115
• Report Number: 3005180920-2023-00406
• Device Sequence Number: 15010783
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• 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: 2012
• Device Explanted Year: 2023
• 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): 06/28/2023

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: 05/23/2012
• Device Model Number: 02.07.2004L
• Device Catalogue Number: 02.07.2004L
• Device Lot Number: 120962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2012
• 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