MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 5.5MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	496S055
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had a loosening line about 10 months post-op.2 years post-op the bone resorption seems to be progressing, and there is a gap visible between the osteotomy surface and the stem.The patient has no complaints and is under observation.
Event or Problem Description
It was reported that the patient had a loosening line about 10 months post-op.2 years post-op the bone resorption seems to be progressing, and there is a gap visible between the osteotomy surface and the stem.The patient has no complaints and is under observation.
Additional Manufacturer Narrative
The reported event could be confirmed since x-ray images were provided and shows loosening of the implant.Upon further investigation of the x-ray images by healthcare professionals the following was observed: there is a radial head replacement with a reasonable positioning visible on the x-ray.Two years later a significant radiolucence and protrusion proximally has occurred.Radiologically loosening seems to be visible, here.Clinically, however, it seems as if the patient would not have any problems and there is no clinical sign of loosening.The bone resorption is likely due to loosening.There is a small chance that the implant has adapted to the surrounding anatomy and will stay stable in this position with future radiological consolidation.The root cause of the reported issue could not be conclusively determined.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use were reviewed and states: in any surgical procedure, the potential for complications exists.The risks and complications with these implants include loosening or dislocation of the prosthesis requiring revision surgery and bone resorption or over-production.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: EVOLVE STEM 5.5MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19697329
• Report Number: 3010667733-2024-00424
• Device Sequence Number: 18173250
• Product Code: KWI
• UDI-Device Identifier: 00840420126238
• UDI-Public: 00840420126238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 496S055
• Device Lot Number: 1720232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2022
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Female