MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date of event: date of device loosening is not known.(b)(4).Date of implant reported as (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date reported as (b)(6) 2016.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review: part number: 04.402.008s, synthes lot number: 9939806, release to warehouse date: 27-apr-2016, expiration date: 28-apr-2021, manufacturer: synthes (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 an unknown procedure in (b)(6) 2016 for a radial head prosthesis procedure of the right elbow.A hardware removal was performed on (b)(6) 2017 due to patient complaint of pain of right elbow.A loosened stem was confirmed upon an x-ray follow-up.There were no issues during the hardware removal and no time delay reported.The procedure was successfully completed.Patient was stable.Concomitant devices reported: 24mm cocr radial head standard height (part 09.402.024s, lot 7504369, quantity 1).This report is for one (1) 8mm straight radial stem 28mm.This is report 1 of 1 for (b)(4).

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-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: 6899236
• MDR Text Key: 87586761
• Report Number: 1719045-2017-10991
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 9939806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention