MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

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

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a patient with primary total shoulder prosthesis returned with pain.An arthroscopy was performed (b)(6) 2014 which showed signs of infection and a loose glenoid.Antibiotics were prescribed and a reoperation was planned to extract everything and change to an arthrex prosthesis, which they normally use.The epoca stem (un-cemented) was impossible to extract, the instrument broke and they had to change the plan.The decision was to put in a new epoca glenoid, eccenter and head.This resulted in a 1 hour delay, the patient slept in the operating room while the surgeon waited for the equipment.A new epoca glenoid,,all poly,was implanted together with a revision epoca eccenter and epoca head.The reason for the failure was the screw ( 03.401.077) in the extraction instrument (03.401.072 ) that broke.This report is for the epoca head, part and lot number unknown.This is report 5 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of birth reported only as 1954.This report is for the epoca head, part and lot number unknown.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.

Manufacturer Narrative

A manufacturing evaluation was completed: it was concluded that the issue must have been due to user error.The screw is conformed according to the draw.No measure was able to be taken.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.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3870801
• MDR Text Key: 4565989
• Report Number: 2520274-2014-11762
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 120