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

Device Problem Naturally Worn (2988)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown epoca device/unknown lot.Part and lot number are unknown; udi number is unknown.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

Device report from synthes europe reports an event in the (b)(6) as follows: it was reported that the surgeon used the epoca shoulder system in an osteoarthritic patient for which he performed a total prosthetic replacement using the metal backed glenoid.The surgeon had to perform a revision due to polymetric wear.The patient presented to the clinic with deteriorating function and pain following good initial post-operative improvements.The revisions was performed between five and seven (5-7) years post-operatively.This report is for an unknown epoca device.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6108245
• MDR Text Key: 60071578
• Report Number: 2520274-2016-15416
• 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: 11/16/2016
• 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