MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L; KNEE TIBIAL INSERT

Model Number 02.12.0311FL

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 17 february 2020: lot 179651: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-04-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting discomfort due to stiffness in the knee.The surgeon revised the medacta sphere insert flex left 11mm s3 with a medacta sphere insert flex left 10mm s3 13 days after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
• Type of Device: KNEE 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: 9805224
• MDR Text Key: 190325628
• Report Number: 3005180920-2020-00153
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030862564
• UDI-Public: 07630030862564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140826
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: 02.12.0311FL
• Device Catalogue Number: 02.12.0311FL
• Device Lot Number: 179651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2018
• 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