MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Reported patient height was 6'3 feet.This report is for an unknown radial head/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on june 23, 2014, the patient underwent a left radial head replacement and a repair of left lateral ulnar collateral ligament avulsion after he fell about 8 feet off a ladder and suffered an injury to his left elbow on (b)(6) 2014.He had x-rays that showed a comminuted fracture of the radial head with significant displacement.There was no dislocation noted.Patient had patient participated in physical therapy post-operatively.On (b)(6) 2015, the patient fell onto his left elbow and has been having significant pain since that time.On (b)(6) 2019, the patient had a clinic visit for left elbow pain, stiffness and limited range of motion.Patient continues to report pain and limited range of motion.No revision surgery has been planned at this time.This is report 2 of 2 for (b)(4).This report is for an unknown radial stem.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the complaint device was not received for investigation.The pictures were reviewed and the reason for the cause of pain and stiffness cannot be determined from the pictures.Based on the records and field action information us cq can confirm the complaint for stem loosening but no issues were identified with the radial heads.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and investigations.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9595658
• MDR Text Key: 175237937
• Report Number: 2939274-2020-00218
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 98