MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, ELBOW, HEMI-RADIA, POLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Patient id: (b)(6).This report is for one (1) unknown radial stem.(b)(4).This report is for one (1) unknown radial stem.An image reading of the x-rays was conducted by a medical director from this manufacturer.The medical director says, he can see decreased bone density in the area around the prosthesis stem.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.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 patient had a revision surgery to the left elbow on (b)(6) 2015; despite the surgery osteolysis progressed.Post-operatively the patient was still having progressive pain, was disabled and also had inflammation.On (b)(6) 2016, the left radial head long stem implant was explanted intact.The patient had some osteoarthritis in the remaining joint, which is likely a consequence of his original injury and it is hard to know the relationship with the radial head osteolysis.The patient also, had similar pain symptoms in his right elbow with swelling; radiographs were taken and osteolysis was present.It was reported that the patient's status outcome and surgical delay was stable.This complaint captures the 3rd revision surgery and following com numbers captures the other three revision surgeries: com-(b)(4): 1st revision.Com-(b)(4): 2nd revision.Com-(b)(4): 4th revision.This report is for one (1) unknown radial stem.This report is 3 of 4 for com-(b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIA, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6071201
• MDR Text Key: 58920258
• Report Number: 2520274-2016-15144
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 77