MAUDE Adverse Event Report: UNKNOWN PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Device Problems Fitting Problem (2183); Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that a curved radial head stem did not fit correctly during a left radial head prosthesis revision.They were replacing a short stem to a long stem.The patient complained of pain and it was identified that the original prosthesis had "wollered out" (migrated).The date of the original procedure (with a competitor's device) is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17537641
• MDR Text Key: 321047141
• Report Number: MW5144491
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1