MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.027S

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient had fractured his left ulna and radial head in a motorcycle racing accident in (b)(6) 2014.The ulna fracture was repaired using a synthes olecranon plate.Radial head fracture was replaced with a synthes radial head and a 7 mm radial stem.This surgery was completed with no complications.In (b)(6) 2015, the patient dislocated his left shoulder in a motorcycle racing accident.During rehab he complained of elbow pain.X-rays were taken at this time, showing that the radial head and stem have disassociated.The retaining screw in the radial head was broken allowing the head to come off the stem.The surgeon chose to cut off the top of the stem.The olecranon plate in the left ulna was fine and there is no complaint against that implant.On (b)(6) 2015, the surgeon removed the radial stem.The removal of the implant was difficult and required additional intervention, consisting of drilling a hole in the stem and removing it using a conical extraction screw set.It was successfully retrieved and the surgeon replaced it with a competitor¿s radial head implant with arthroplasty of the radial head.There was no surgical time delay.The procedure was completed successfully.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Expiration of december 2017.There were no material review records, 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.

• Brand Name: 7MM TI CURVED RADIAL STEM 42MM-STERILE
• 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: 4488905
• MDR Text Key: 15912811
• Report Number: 1719045-2015-10089
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7012310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention