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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn.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.

Event Description

It was reported that on an unknown date, a patient came for a follow-up and complained discomfort.Originally, patient was implanted with radial prosthesis on (b)(6) 2016.A follow up xray was done during the visit and showed loosening of the radial stem, there was no malfunction of the radial head.There was no revision procedure scheduled for the patient as confirmed by the surgeon.Concomitant device reported: unknown radial head (part # unknown, lot # unknown, quantity 1) device report.This complaint involves one (1) device.

Event Description

This report is for an unknown radial head 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.Additional information provided.Date of implantation is an unknown date in (b)(6) 2016.Date of concomitant therapy is the same as date of implantation; an unknown date in (b)(6) 2016.Code 3191 used to capture the potential need for medical/surgical intervention.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.

• 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: 8056565
• MDR Text Key: 126711387
• Report Number: 2939274-2018-54918
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• 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: 12/13/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention