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 Problem Malposition of Device (2616)

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

Event Type  Injury  

Event Description

It was reported postoperatively the patient was experiencing pain associated with the radial prosthesis.The original radial prosthesis was implanted on (b)(6) 2014 and the surgery went as planned.On (b)(6) 2014 postoperative x-rays revealed osteolysis and loosening of the radial prosthesis.Additional postoperative x-rays have been required to monitor healing.The surgeon is planning on revising the patient in the near future.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates avalign technologies-nemcomed manufactured the 20mm cocr radial head, part #09.402.220 and lot #6905662 on po (b)(4) dated august 8, 2012 (b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated august 7, 2012 and to synthes final inspection sheet (b)(4), revision ¿a¿.The parts were labeled, packaged, sterilized (po #(b)(4)) at sterigenics (corona) and released to the warehouse on august 31, 2012, with expiration date july 2017.There were no mrr¿s, ncr¿s, or complaint related issues with this lot.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.

• 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: 4474594
• MDR Text Key: 21780228
• Report Number: 1719045-2015-10080
• 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
• 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?: Yes
• Date Manufacturer Received: 01/20/2015
• 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