MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R; KNEE INSERT PE

Model Number 02.12.E0310CRR

Device Problem Material Rupture (1546)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/19/2022

Event Type  Injury  

Event Description

At 5 days after the primary, the patient came in reporting pain due to a quad tendon rupture and the cause is unknown.The surgeon performed a quad tendon repair and upsized the poly.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 29 july 2022.Lot 2112612: (b)(4) items manufactured and released on 01-dec-2021.Expiration date: 2026-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R
• Type of Device: KNEE INSERT PE
• 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: 15240605
• MDR Text Key: 298048383
• Report Number: 3005180920-2022-00613
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630971261501
• UDI-Public: 07630971261501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202022
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.E0310CRR
• Device Catalogue Number: 02.12.E0310CRR
• Device Lot Number: 2112612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• 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 Sex: Female