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

Catalog Number 04.402.027S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufactured by supplier (b)(4), packaged by: (b)(4).Release to warehouse date: 13-mar-2015.Expiration date: 29-feb-2020.Part #: 04.402.027s, lot#: 7855649 (sterile).The 7 mm ti curved radial stem 42 mm - sterile, quantity 23.(b)(4) material, lot number: 7506606.No nonconformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this 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 the patient was originally implanted with a 7 mm curved radial stem implant and a 20 mm radial head implant on (b)(6) 2016 for a fractured proximal ulna.Reason for fracture is unknown.Patient presented with pain and a non-union.Also, the surgeon observed thru images on an unknown date the implant was loose.A follow up procedure was performed on (b)(6) 2017.Both implants were removed.Patient was not revised to any other implants.The removed implants were observed to be in good condition.No fragments were generated during the explant.Patient is reported in stable condition and the explant surgery was completed successfully.This is report 2 of 2 for com-(b)(4).

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: 7MM TI CURVED RADIAL STEM
• 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: 6348685
• MDR Text Key: 67930713
• Report Number: 1719045-2017-10126
• 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
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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: 04.402.027S
• Device Lot Number: 7855649
• 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: 03/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR