MAUDE Adverse Event Report: ACUMED LLC LEFT RADIAL HEAD IMPLANT; 24.0 LEFT RADIAL HEAD

Catalog Number REF: TR-H2406-S

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Loss of Range of Motion (2032)

Event Date 12/10/2015

Event Type  Other  

Event Description

Accumed representative handed off wrong implant to the field and product was implanted in patient.Patient was scheduled for a right radial head arthroplasty and the accumed rep handed over the implant for a left radial head arthroplasty.It was implanted by the surgeon and was not discovered until completing the implant log at the end of the procedure.The surgeon was notified immediately and checked for full range of motion.Felt patient could lose 30 degree rotation.Opted not to replace due to high potential of fracture in the radial head on removal.Reason for use: repair of fractured elbow.

• Brand Name: LEFT RADIAL HEAD IMPLANT
• Type of Device: 24.0 LEFT RADIAL HEAD
• Manufacturer (Section D): ACUMED LLC; hillsboro OR 97124
• MDR Report Key: 5403673
• MDR Text Key: 37427193
• Report Number: MW5059831
• Device Sequence Number: 1
• Product Code: KWI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: REF: TR-H2406-S
• Device Lot Number: 347513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR