MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; FEMORAL KNEE COMPONENT

Catalog Number	02.12.0006L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary kinematic total knee arthroplasty tka on (b)(6) 2023.Subsequently, the patient came in reporting pain following a traumatic event from jumping into a pool that caused a patella dislocation.On (b)(6) 2023, the surgeon performed a release of soft tissue and sutured to force the patella more medial.No implants were revised.Presently, the patient came in reporting pain in the knee.The patient was still having patella alignment issues so the surgeon decided to revise the patient to reposition the femur for better patella tracking.The surgeon revised the femoral component, insert and tibial tray successfully.
Additional Manufacturer Narrative
Batch review performed on 29 november 2023: lot 2211527: 20 items manufactured and released on 20-july-2023.Expiration date: 2027-07-10.No anomalies found related to the problem.To date, 17 items of the same lot have been sold without any similar reported event in the period of review.Additional implant involved, batch review performed on 24 november 2023: gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 2246249: 115 items manufactured and released on 13-mar-2023.Expiration date: 2028-02-23.No anomalies found related to the problem.To date, 99 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: FEMORAL KNEE 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: 18281306
• Report Number: 3005180920-2023-00991
• Device Sequence Number: 15018674
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/07/2023

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 Catalogue Number: 02.12.0006L
• Device Lot Number: 2211527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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