MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SINCE 4+ L; KNEE FEMORAL CEMENTED COMPONENT

Model Number	02.12.0024L
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	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary, the patient came in reporting pain due to aseptic loosening and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 december 2022: lot 179599: (b)(4) items manufactured and released on 16-apr-2018.Expiration date: 2023-04-05.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Additional device involved batch review performed on 30 december 2022: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 (k090988) lot 179500: (b)(4) items manufactured and released on 11-apr-2018.Expiration date: 2023-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.
Additional Manufacturer Narrative
Information changed in this fu 1: in the initial report it was inserte the data of implantation (section d6a) (b)(6) 2022.The data has been corrected in (b)(6) 2018.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SINCE 4+ L
• Common Device Name: KNEE FEMORAL CEMENTED 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: 16157352
• Report Number: 3005180920-2022-01010
• Device Sequence Number: 6958818
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 04/05/2023
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 179599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2018
• 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