MAUDE Adverse Event Report: SYNTHES MONUMENT 6MM TI CURVED RADIAL STEM 40MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.026S

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Originally implanted on an unknown date in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: manufacturing location: manufacturing location: (b)(4), packaged by: (b)(4).Manufacturing date: 30-mar-2015.Expiration date: 29-feb-2020.Part #: 04.402.026s, lot#: 7838228 (sterile) - 6 mm ti curved radial stem 40mm-sterile.Quantity (b)(4).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.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 radial head replacement, implanted on an unknown date in (b)(6) 2016 by an unknown surgeon, came loose and had to be explanted.Both the radial head and stem were removed on (b)(6) 2017.During the procedure it was not that the radial head was intact and attached to the stem.The radial head displayed no noted device malfunction.Both devices were easily removed intact.The radial stem did not require any effort to be removed as it was noted to have considerably loosened in the canal and, subsequently, slid right out.No additional medical intervention was required.There were no surgical delays and no harm to the patient.It is unknown if the patient suffered any permanent damage or had any motion compromised.The device were explanted and were not replaced.The surgery was successfully completed and the patient was noted to be stable at the end of surgery.Concomitant devices reported: radial head (part # 04.402.022s, lot # 7855829 , quantity 1).This complaint involves two (1) device.

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.

Manufacturer Narrative

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

Both the radial head and stem were removed on (b)(6) 2017 as initially reported.

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.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: 6MM TI CURVED RADIAL STEM 40MM-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: 6282725
• MDR Text Key: 65941443
• Report Number: 1719045-2017-10060
• 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,Followup,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 04.402.026S
• Device Lot Number: 7838228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (PART # 04.402.022S, LOT # 7855829
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR