MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE HEAD 20MM +4; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 496H420

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

Patient Problem Bone Fracture(s) (1870)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.

Event Description

The doctor had a radial head replacement case that took place on (b)(6) 2023.During the procedure, a slight fracture was noticed at the base of the proximal radius where the native radial head was cut off.Dr.(b)(6) elected to perform an osteotomy at this location to provide a solid implant site for the evolve proline stem, utilizing the available options to accommodate this action.The case presented significant challenges, but after the trial and final implantation of the stem and head, no further fractures were noticed intraoperatively.On (b)(6) 2023 the doctor reported that the patient from this case had a fracture at the stem location of the proximal radius, which was discovered through x-ray during the follow-up.

Event Description

The doctor had a radial head replacement case that took place.During the procedure, a slight fracture was noticed at the base of the proximal radius where the native radial head was cut off.The doctor elected to perform an osteotomy at this location to provide a solid implant site for the evolve proline stem, utilizing the available options to accommodate this action.The case presented significant challenges, but after the trial and final implantation of the stem and head, no further fractures were noticed intraoperatively.At a later day, the doctor reported that the patient from this case had a fracture at the stem location of the proximal radius, which was discovered through x-ray during the follow-up.

Manufacturer Narrative

The complaint was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order 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 HEAD 20MM +4
• Type of Device: 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: 17469063
• MDR Text Key: 320482459
• Report Number: 3010667733-2023-00428
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 496H420
• Device Lot Number: 1668284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female