MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L; KNEE FIXED TIBIAL INSERT

Model Number 02.12.0412FL

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 11 april 2022 lot 2005755: (b)(4).Expiration date: 2025-07-30.No anomalies found related to the problem.(b)(4).

Event Description

Revision surgery was performed 6 months after the primary due to tightness in the knee.The surgeon revised successfully the insert (12mm to 10 mm).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L
• Type of Device: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14249026
• MDR Text Key: 290368641
• Report Number: 3005180920-2022-00307
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826573
• UDI-Public: 07630030826573
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0412FL
• Device Catalogue Number: 02.12.0412FL
• Device Lot Number: 2005755
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2020
• 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 Age: 81 YR
• Patient Weight: 70 KG