MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L; KNEE TIBIAL INSERT

Model Number 02.12.0511FL

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 07/11/2022

Event Type  Injury  

Event Description

At about 2 years after the primary surgery, the patient came in reporting instability due to laxity.The surgeon revised the insert (11mm) with a thicker one (14mm) to give the patient more stability.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 18-jul-2022: lot 177403: 50 items manufactured and released on 01-mar-2018.Expiration date: 2023-02-09.No anomalies found related to the problem.To date, 42 items of the same lot have been sold with other 2 similar reported case during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 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: 15154693
• MDR Text Key: 297141303
• Report Number: 3005180920-2022-00585
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030862649
• UDI-Public: 07630030862649
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/03/2022

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 Expiration Date: 02/09/2023
• Device Model Number: 02.12.0511FL
• Device Catalogue Number: 02.12.0511FL
• Device Lot Number: 177403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2018
• 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
• Patient Sex: Male