MAUDE Adverse Event Report: SYNTHES MONUMENT 28MM COCR RADIAL HEAD 2MM HT EXTENSION/16.0MM-STER; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 09.402.228S

Device Problems Detachment Of Device Component (1104); Component or Accessory Incompatibility (2897)

Patient Problems Pain (1994); Sedation (2368)

Event Type  Injury  

Event Description

It was reported that the patient had an original implant surgery of radial head prosthesis in (b)(6) 2014.The patient had been experiencing pain.X-rays taken showed that the head was backing off of the stem.The revision surgery was done on (b)(6) 2015.The surgeon was unable to remove the screw from within the radial head and the screw broke off into the titanium stem.The head was brought out and the stem was unable to come out due to the screw breaking off.There was a 30-45 minute surgical delay.The stem was left in the patient.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Implant date: (b)(6) 2014.A review of the device history records was performed.There were no material record reviews, nonconformance reports, or complaint related issues with this lot.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

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.

• Brand Name: 28MM COCR RADIAL HEAD 2MM HT EXTENSION/16.0MM-STER
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4476742
• MDR Text Key: 21451756
• Report Number: 1719045-2015-10083
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 09.402.228S
• Device Lot Number: 6892449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention