MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.12.0025L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause is unknown.About 1 year and 2 months after the primary surgery, the surgeon revised all components and switch to a revision system, and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 187167: 59 items manufactured and released on (b)(6) 2018.Expiration date: 2023-nov-26.No anomalies found related to the problem.To date, 57 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implants: batch review performed on (b)(6) 2023 on gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.2013140 lot 2013140: 119 items manufactured and released on (b)(6) 2021.Expiration date: 2026-07-27.No anomalies found related to the problem.To date, 114 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on (b)(6) 2023 on gmk-sphere 02.12.0413fl tibial insert fixed sphere flex size 4/13 mm l (k140826) lot.183019 lot 183019: 25 items manufactured and released on (b)(6) 2018.Expiration date: 2023-jul-11.No anomalies found related to the problem.To date, 19 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 5+ L
• Common Device Name: KNEE CEMENTED 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: 16276069
• Report Number: 3005180920-2023-00009
• Device Sequence Number: 17855507
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/31/2023

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: 11/26/2023
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 187167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2018
• 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