MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GAAK PRIMARY TIBIAL INSERT FIXED, FEMORAL COM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number REF02.12.0410FR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Patient was undergoing elective l knee replacement surgery.R knee implant was briefly implanted in the l knee, but rapidly recognized by vendor when he went to mark product in his log book.Wrong implant was able to be removed immediately as cement had not dried, thus avoiding a major revision surgery.Upon review of this incident, the team felt that the product should have enhanced laterality labelling.Fda safety report id# (b)(4).

• Brand Name: GAAK PRIMARY TIBIAL INSERT FIXED, FEMORAL COM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA
• MDR Report Key: 15121554
• MDR Text Key: 296856911
• Report Number: MW5111156
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF02.12.0410FR
• Device Lot Number: 2110142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 102 KG