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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient weight not available for reporting.Date patient pain began is not known.510k: this report is for an unknown radial head/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant reported only as 2014 or 2015.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a procedure to implant the radial head prosthesis on unknown date in 2014 or 2015.Patient also reported another surgical procedure involving pinning of the forearm on an unknown date for an unknown purpose.Patient stated an adjustment procedure of the previously implanted radial head prosthesis was performed on an unknown date due to the radial head movement causing the forearm to push on his wrist.Patient further reports the need for ice and heat treatments due to increased pain over the last several weeks.Patient has not yet been seen by a physician/surgeon regarding the pain, no procedure/revision is scheduled.Patient¿s recent pain is addressed in (b)(4).This report addresses the adjustment procedure.(b)(4).

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7151656
• MDR Text Key: 95947917
• Report Number: 2939274-2017-50474
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention