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

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Type  malfunction  

Manufacturer Narrative

Literature citation: yu-xing wang et al.Surgical treatment of ?terrible triad of the elbow?: technique and outcome.Orthopaedic surgery.2010; volume 2: 141-148.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, in an article by wang et al.Titled "surgical treatment of terrible triad of the elbow: technique and outcome" it was reported that in one patient, the radial head fracture was too comminuted to be repaired, so the surgeon chose a titanium radial head prosthesis.Sometime post-op there was residual subluxation.

• Brand Name: EVOLVE (R)
• 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: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7926466
• MDR Text Key: 122632332
• Report Number: 1043534-2018-00155
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR