MAUDE Adverse Event Report: SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

(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 (b)(6) as follows: clinical study: it was reported that a humeral head necrosis occurred followed by implantation of a prosthesis.This incident occurred six (6) months until one (1) year postoperatively.The implant surgery was on (b)(6) 2015 and the revision took plate on (b)(6) 2016.The involved patient is female, was born in (b)(6) and has recovered.This report is for an unknown cement kit.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

(b)(6) an alert date of (b)(6) 2016 was initially reported, however it was confirmed that the correct alert date of the adverse event was (b)(6) 2016.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

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

It was reported the adverse event (ae) was detected on (b)(6) 2016, which was the 12 month follow up visit; the shoulder was x-rayed during that visit.On (b)(6) 2016, the patient was treated with prosthesis and was admitted to the hospital.

• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 5440928
• MDR Text Key: 38318948
• Report Number: 2520274-2016-11096
• Device Sequence Number: 1
• Product Code: NDN
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• 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: 03/22/2016
• 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