MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. EVOLVE HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number 496H222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a radial head replacement operation.It is alleged that the surgeon went over the procedure prior to surgery and was going to perform a left radial head fracture procedure however during the procedure changed to a left radius head replacement.It is also alleged that after the operation, the surgeon did not tell the patient how to effectively conduct rehabilitation training, and the patient's elbow could not return to normal function.The patient was not satisfied with the results with flexion and extension.

• Brand Name: EVOLVE HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12163324
• MDR Text Key: 261439743
• Report Number: 0001043534-2021-00118
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00840420185723
• UDI-Public: 00840420185723
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 496H222
• Device Catalogue Number: 496H222
• Device Lot Number: 1638029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other