MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. KATALYST RADIAL HEAD REPLACEMENT; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number 06-1000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2018

Event Type  Injury  

Event Description

Dissociation of bipolar radial head implant head from stem components.No fall or injury associated; happened during normal daily activity.Ct was obtained confirming these findings.Patient did not have the implant removed although it was advised and would likely lead to loss of motion.Fda safety report id# (b)(4).

• Brand Name: KATALYST RADIAL HEAD REPLACEMENT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP. ; princeton NJ 08540
• MDR Report Key: 10005010
• MDR Text Key: 189349061
• Report Number: MW5094286
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2020

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 Expiration Date: 02/23/2021
• Device Model Number: 06-1000
• Device Catalogue Number: 221675
• Device Lot Number: KV0116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 82