MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0002R
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2022.Lot 2000481:(b)(4) expiration date: 2025-04-16.No anomalies found related to the problem.(b)(4).Other devices involved: batch review performed on 01 april 2022 gmk-sphere 02.07.1203r tibial tray fixed cemented # 3 r (k090988) lot 2005689: (b)(4).Expiration date: 2025-09-17.No anomalies found related to the problem.(b)(4).Gmk-sphere 02.07.0035rp patella resurfacing # 3 (k0909889 lot 2006037: (b)(4).Expiration date: 2025-07-21.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in reporting pain due to aseptic loosening of tibia, femur, and patella and the cause is unknown.The surgeon revised all components 10 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
• Common Device Name: FEMORAL COMPONENT 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: 14239391
• Report Number: 3005180920-2022-00298
• Device Sequence Number: 5044070
• Product Code: JWH
• UDI-Device Identifier: 07630030825804
• UDI-Public: 07630030825804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/28/2022

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: 04/16/2025
• Device Model Number: 02.12.0002R
• Device Catalogue Number: 02.12.0002R
• Device Lot Number: 2000481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2020
• 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