MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.220S

Device Problems Component or Accessory Incompatibility (2897); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the there was a concern with a radial head prosthesis and postoperative loosening of the stem.The patient had surgery on (b)(6) 2014.X-ray confirmed on (b)(6) 2014 that the stem had loosened.The device is still implanted in the patient; a revision surgery reportedly appears inevitable but has not yet been scheduled.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Expiration date july 2017.A review of the device history records was performed.There were no material review records, nonconformance reports, or complaint related issues with this lot.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).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: 20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-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: 4475742
• MDR Text Key: 19351822
• Report Number: 1719045-2015-10079
• 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: Company Representative
• Reporter Occupation: Other
• 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 Catalogue Number: 09.402.220S
• Device Lot Number: 6905662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention