MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; KNEE FEMORAL COMPONENT

Model Number	02.12.0006L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain.The xrays indicated that the implants were loose.At about 1 year and 9 months after the primary surgery, during revision surgery, the surgeon noted femur and tibia were able to be removed with mild to moderate distraction force.The surgeon revised the femur, tibia, and insert and the surgery was completed successfully.Revision system implanted.
Additional Manufacturer Narrative
Batch review performed on 1 december 2022.Lot 2005347: (b)(4) items manufactured and released on 21-sep-2020.Expiration date: 2025-sep-09.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.Additional device involved: batch review performed on 1 december 2022.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l ((b)(4)), lot: 2005043: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-sep-27.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-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• 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: 16023348
• Report Number: 3005180920-2022-00943
• Device Sequence Number: 17588734
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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): 12/21/2022

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: 09/09/2025
• Device Model Number: 02.12.0006L
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 2005347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2020
• 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