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

Catalog Number 02.12.0006L

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 11/13/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 329887178
• Report Number: 3005180920-2023-00991
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 2211527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male