MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L; KNEE TIBIAL TRAY CEMENTED

Model Number	02.07.1203L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 years and 9 months after the primary, the patient came in reporting pain due to loose implants and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 april 2022.Lot 189129: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional component involved: gmk-sphere 02.12.0023l femoral component sphere cemented size 3+ l (k140826) lot.188920: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: KNEE TIBIAL TRAY 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: 14336939
• Report Number: 3005180920-2022-00357
• Device Sequence Number: 5199177
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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: 02/21/2024
• Device Model Number: 02.07.1203L
• Device Catalogue Number: 02.07.1203L
• Device Lot Number: 189129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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: Female