MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 8.5MM; Prosthesis, Elbow, Hemi-, Radial, Polymer

Catalog Number	496S085
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "a case in which evolve was implanted on april 7.Postoperative follow-up x-rays confirmed separation between the stem and the head.Revision surgery is scheduled for april 28.".
Event or Problem Description
As reported: "a case in which evolve was implanted on(b)(6).Postoperative follow-up x-rays confirmed separation between the stem and the head.Revision surgery is scheduled for (b)(6).".
Additional Manufacturer Narrative
Correction - please refer to h6 device code.The reported event could not be confirmed based on evaluation available x-rays.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.No indications of material, manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon review of available x-rays medical expert opined that the dissociation of the radial head from the stem can be confirmed based on the available radiographic images.Review of the x-rays does not indicate an apparent device-related failure.However, a definitive determination would require examination of the explanted device itself.One possible explanation for the observed dissociation is malalignment of the radial head implant center relative to the articulating surface of the radiocapitellar joint.Such mispositioning may generate eccentric joint loading and levering forces across the implant construct, potentially resulting in separation of the radial head from the stem over time.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: EVOLVE STEM 8.5MM
• Common Device Name: Prosthesis, Elbow, Hemi-, Radial, Polymer
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): Wright Medical Technology, Inc.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25217214
• Report Number: 3010667733-2026-00504
• Device Sequence Number: 21284698
• Product Code: KWI
• UDI-Device Identifier: 00840420126269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 496S085
• Device Lot Number: 1801811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male