MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0007R FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R; KNEE FEMORAL COMPONENT

Model Number	02.12.0007R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for femoral loosening at about 3 years and 8 months post primary.Liner and femur revised successfully.
Additional Manufacturer Narrative
Batch review performed on 11 january 2023: lot 123714a: 1 items manufactured and released on 09-apr-2018.Expiration date: 2023-03-21.No anomalies found related to the problem.

• Brand Name: GMK-SPHERE 02.12.0007R FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 16329560
• Report Number: 3005180920-2023-00019
• Device Sequence Number: 18288416
• Product Code: JWH
• UDI-Device Identifier: 07630030825903
• UDI-Public: 07630030825903
• 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: 2019
• 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): 02/08/2023

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: 03/21/2023
• Device Model Number: 02.12.0007R
• Device Catalogue Number: 02.12.0007R
• Device Lot Number: 123714A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2018
• 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