MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.This report is for one (1) unknown epoca.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.(b)(6).This report is for one (1) unknown epoca.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that the patient needed a revision surgery on (b)(6) 2017 of an epoca implant.The revision was due to polyethylene wear.No additional information about patient condition and outcome were reported.This report is for one (1) synflate balloon/small-sterile.This is report 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6361320
• MDR Text Key: 68417879
• Report Number: 2520274-2017-10615
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention