MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L; KNEE TIBIAL INSERT

Model Number 02.12.0410FL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 december 2022.Lot 2108899: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-aug-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: few months after primary cemented tkr in a young female patient, instability is perceived while the implants are otherwise performing properly.Secondary instability is a possible adverse event following tkr and it's mainly due to disease progression.No reason to suspect a faulty device at the origin of this complaint.

Event Description

Revision surgery performed about 9 months after the primary surgery due to knee laxity.The insert was revised from 10 mm to 13 mm.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
• Type of Device: KNEE TIBIAL INSERT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16032555
• MDR Text Key: 305972598
• Report Number: 3005180920-2022-00967
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0410FL
• Device Catalogue Number: 02.12.0410FL
• Device Lot Number: 2108899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 63 KG