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

Device Problem Device Slipped (1584)

Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); No Code Available (3191)

Event Date 12/14/2014

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head prosthesis: radial stem/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 the radial head implant system that was implanted on or about (b)(6) 2014 failed.The failure resulted in pain and weakness on the patient's left elbow and surrounding regions, loss of range of motion, and loosening of the components.A revision surgery was performed last (b)(6) 2019 after x-rays confirmed loosening of the radial head/ stem implant.It was recommended to undergo a revision surgery.There is no further information available.This report is for one (1) unk - radial head prosthesis: radial stem.This is report 2 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.H10: additional narrative: h3, h6: a photo investigation was completed: the device was not returned.A photo-investigation was performed on the provided images.The images appeared to be intra-op fluoroscopy images of the replacement surgery performed on (b)(6) 2019.These images depicted an unknown device, resembling a non-synthes long stem anatomic radial head system.Per the medical records provided, this appeared to be the replacement device.No depuy synthes devices were observed.No issues were observed.The reported condition could not be confirmed with the received images.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.The complaint could not be confirmed during photo investigation, as the device was not depicted in the images.However, there are known issues with the radial head implants; the issue was attributed to design control process issues, which have been addressed.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: 10542589
• MDR Text Key: 207723570
• Report Number: 2939274-2020-04168
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR