MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; KNEE TIBIAL INSERT

Catalog Number 02.12.0411FR

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06 november 2019.Lot 1810395 : 175 items manufactured and released on 20-mar-2019.Expiration date: 2024-03-04.No anomalies found related to the problem.To date, 48 items of the same lot have been already sold without any other similar reported event.

Event Description

Revision surgery performed 2 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the insert successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
• 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: 9368476
• MDR Text Key: 170445478
• Report Number: 3005180920-2019-00987
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• 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: 11/25/2019

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: 03/04/2024
• Device Catalogue Number: 02.12.0411FR
• Device Lot Number: 1810395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2019
• 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