MAUDE Adverse Event Report: SYNTHES MONUMENT 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.006S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Expiration date: 30-jun-2020.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record review was performed for the subject device lot number 7855586.Manufacturing location: supplier (b)(4).Packaged by: (b)(4).Date of manufacture: 17-jul-2015.Expiration date: 30-jun-2020.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.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 had a scheduled revision on (b)(6) 2017 for the removal of a radial head, due to loosening.The patient also became aware of the recall and wanted explanted.The implants were intact.She was revised to a competitor¿s device.The surgery was completed successfully with no surgical time delay.The patient was stable following surgery, no additional medical intervention was required.The reason for explant was radial head stem was loose in the medullary canal.Surgeon did not separate the radial head for radial stem when explanting, he removed the devices while they were still connected.The radial head was not loose and was not loose from radial stem during the time of implantation.Concomitant medical products: radial head (head) (part # 09.402.222s, lot # 9939884, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.A product development investigation was performed.The returned 04.402.006s titanium straight radial stem (lot# 7855586) was reported to have been revised and explanted due to patient complaining about postoperative loosening.This complaint condition has been investigated and resulted in recall and the voluntary product removal of the radial head prosthesis system.The issue has already been identified and appropriate actions have been taken to address the issue.This complaint is unconfirmed as no x-rays or evidence was provided and based on the following provided info "surgeon did not separate the radial head for radial stem when explanting; he removed the devices while they were still connected.The radial head was not loose and was not loose from radial stem during the time of implantation." part 09.402.222 (lot# 9939884) was returned as a concomitant device without an alleged complaint condition.It is a part of radial head prosthesis system.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 STRAIGHT RADIAL STEM 24MM-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: 6573365
• MDR Text Key: 75402040
• Report Number: 1719045-2017-10478
• 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: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Catalogue Number: 04.402.006S
• Device Lot Number: 7855586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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