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

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

This report is for 1 unknown epoca shoulder system.Date of implant and date of explant are unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).This report is for 1 unknown epoca shoulder system.Pma/510(k) number is not available.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 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 the surgeon used the epoca shoulder system predominantly in osteoarthritic patients for whom he performed a total prosthetic replacement using the metal backed glenoid.It was reported that following initial post-operative improvements, patients return to clinic with deteriorating function and pain.The surgeon has had to perform revisions due to plyometric wear.Reportedly, the revisions are being performed between five (5) to seven (7) years post-operatively.According to the surgeon, the patient he revised in 2015, demonstrated evidence of metallosis as a result of polyethylene wear.This resulted in the metal glenoid head articulating with the metal backed glenoid component.This complaint is linked to: com-(b)(4): revision due to polymetric wear; functional wear.Com-(b)(4): revision due to polymetric wear; post-op degenerative cuff failure.Com-(b)(4): revision planned, unknown when.This report is for one (1) unknown epoca shoulder system.This is report 1 of 1 for com-(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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6070115
• MDR Text Key: 58925833
• Report Number: 2520274-2016-15136
• 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: Other
• Type of Report: Initial
• Report Date: 10/26/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• 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