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 Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem/ unknown lot.Part and lot number 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 that on (b)(6) 2014, the patient underwent revision surgery, wherein it was noted that the radial head prosthesis was grossly loose at the bone stem interface.The surgeon removed the radial head and stem and replaced this with another synthes radial head (20 mm) and curved stem (7 mm).On or about (b)(6) 2014, the patient fell out of bed injuring her left arm and elbow.X-rays revealed she suffered a fracture of the radial head and neck, along with posterior dislocation of her left elbow.Her elbow dislocation was reduced.On or about (b)(6) 2014, the patient underwent a left radial head replacement, repair of the anterior capsule of left elbow, repair of lateral ulnar collateral ligament left elbow and application of long-arm splint and was implanted with a synthes radial head (22 mm) and straight stem (8 mm).Post-operatively, the patient participated in physical therapy for several months and regained most of her mobility and function.In late (b)(6), early (b)(6) 2014, she began experiencing increasing pain with pronation and supination.This report is for one (1) unknown radial stem.This is report 1 of 2 for (b)(4).

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.H6: photo investigation: the device was not returned.A photo-investigation was performed on the images.The image indicated that there was a significant amount of bone degradation (osteolysis) around the implant, leading to a loose implant condition.No apparent device malfunction, damage or defect was noted in the images.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint of a reported loose implant condition was confirmed during investigation.No manufacturing issues were noted during investigation.There are known issues with the radial head implants that are captured in a capa; the issue was attributed to design control process issues, which have been addressed within the capa.Recall# 555531 was initiated as part of field action investigation.Investigations and assessment of the risks associated with this device were addressed under recall and field action investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no additional corrective and/or preventive action is proposed.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: 11337786
• MDR Text Key: 232329897
• Report Number: 2939274-2021-00905
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 03/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR