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

Catalog Number	02.07.1203R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 july 2024.Lot 1908625: (b)(4) items manufactured and released on 31-march-2020.Expiration date: 2025-03-26.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 revised implants.Batch review performed on 16 july 2024 on gmk-sphere 02.12.0023r femoral component sphere cemented size 3+ r (k140826) lot.1909493.Lot 1909493: (b)(4) items manufactured and released on 25-feb-2020.Expiration date: 2025-02-19.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.Batch review performed on 16 july 2024 on gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm r (k121416) lot.189042.Lot 189042: (b)(4) items manufactured and released on 05-feb-2019.Expiration date: 2024-01-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 3 years 9 months after the primary, the patient came in reporting anterior knee pain and the cause was unknown.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19749505
• Report Number: 3005180920-2024-00530
• Device Sequence Number: 12384902
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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: 03/26/2025
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 1908625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2020
• 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: Female