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

Catalog Number	02.12.0004L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 jun 2024: lot 2342548: (b)(4) items manufactured and released on 16-jan-2024.Expiration date: 2028-12-25.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.Additional device involved batch review performed on 19 jun 2024 gmk-sphere 02.12.E0310fl tibial insert fixed sphere flex size 3/10 mm l e-cross (k202022) lot 2314123: (b)(4) items manufactured and released on 03-jul-2023.Expiration date: 2028-06-13.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.
Event or Problem Description
The incorrect size combination has been implanted due to human error (femur size 4 and tibial insert size 3).The patient was already out of the room when the discrepancy was realized so the revision surgery has been performed the next day.Femur and liner were revised and sphere femur cemented left s3 + and gmk-sphere tibial insert e-cross - flex 3l - 14mm successfully implanted.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19699913
• Report Number: 3005180920-2024-00503
• Device Sequence Number: 17036317
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/09/2024

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 Catalogue Number: 02.12.0004L
• Device Lot Number: 2342548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White