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

Device Problems Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

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.Initial reporter is the patient.The 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 or about (b)(6) 2017, a patient underwent a revision surgery due to a faulty synthes radial head prosthesis system.The patient was originally implanted with a synthes radial head prosthesis system on or about (b)(6) 2016 due to a sustained injury in the elbow.Sometime following (b)(6) 2017, the patient discovered that the implanted device had failed and caused injuries to the patient.This is report 1 of 2 for (b)(4).This report is for an unknown radial head prosthesis 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.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

Updated event description: it was reported that on or about (b)(6) 2017, a patient underwent a revision surgery due to a faulty synthes radial head prosthesis system.The patient was originally implanted with a synthes radial head prosthesis system on or about (b)(6) 2016 due to a sustained injury in the elbow.Sometime following (b)(6) 2017, the patient discovered that the implanted device had failed and caused injuries to the patient.On (b)(6) 2017, the patient was status post prior radial head replacement that was loose and is scheduled for surgery on (b)(6) 2017.The patient had a status post removal of radial head implant with likely lateral epicondylar symptoms on (b)(6) 2017.On (b)(6) 2017, the patient continues to have pain, mostly on the medial side near where her ulnar nerve was.On (b)(6) 2018, the patient had a left elbow ulnar nerve transposition, left radial head arthroplasty.After the surgery, on (b)(6) 2018, the patient has some regional numbness and tingling.On (b)(6) 2018, the patient still complains of pain at night.

• 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: 8696352
• MDR Text Key: 147913632
• Report Number: 2939274-2019-58630
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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: 10/09/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 113