MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 04.402.009S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone not available for reporting.Dhr review was completed.Manufacturing location: supplier (b)(4), packaged by (b)(4), manufacturing date: 24-oct-2014 , expiration date: 30-sep-2019., part #: 04.402.009s, lot#: 7693228 (sterile) - 9 mm ti straight radial stem 30 mm-sterile.Quantity 74.Raw material part 21014 lot 7557656 was reviewed.Raw material was received from perryman company.Certified test report for titanium received from perryman meet specification.Inspection certificate received from vsmpo corporation meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection - meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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

It was reported that a patient underwent a removal of the radial head prosthesis on (b)(6) 2017 due to radiolucency and loosening of the radial stem.Radial head was implanted in the patient on (b)(6) 2016.Subsequently, x-rays suggested that the radial stem was loosening and there was significant radiolucency around the stem in the x-rays.As per the surgeon, the patient was symptomatic.It is not known to what symptoms surgeon was referring.There is no plan to implant any devices at this time in place of the radial head prosthesis.The removal of the radial head was uneventful and the patient is in a stable condition.Concomitant devices reported: radial head (part 09.402.220s, lot 7607089, quantity 1).This report is for one (1) 9 mm straight radial stem.This is report 1 of 1 for (b)(4).

• Brand Name: 9MM TI STRAIGHT RADIAL STEM 30MM-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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6961712
• MDR Text Key: 89726494
• Report Number: 1719045-2017-11087
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7693228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (09.402.220S, LOT 7607089, QTY 1)
• Patient Outcome(s): Required Intervention