MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GENESIS UNIVERSAL P.S. FEMORAL IMPACTOR SCREW; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

During the total knee arthroplasty and while impacting, genesis universal p.S.Femoral impactor screw broke off and went into knee joint.The small screw piece was retrieved without any injury.

• Brand Name: GENESIS UNIVERSAL P.S. FEMORAL IMPACTOR SCREW
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.
• MDR Report Key: 9147032
• MDR Text Key: 161244682
• Report Number: MW5090180
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 84