MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.007S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(6).Event date: unknown.Additional device product code is hwc.(b)(4).(therapy date): unknown.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: apr 27, 2016.Expiration date: mar 31, 2021.The review 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.¿ no non-conformances were generated during the production of the subject device.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 underwent a revision surgery on (b)(6) 2017 to remove a radial head due to loosening of the radial stem.There was no information provided on whether or not the patient had symptoms related to the loose device.The patient was originally implanted with the devices on an unknown date.During the revision the radial head and radial stem were removed whole and intact.There was no reported surgical delay and no harm was reported to the patient during the revision surgery.The surgery was successfully completed.The patient postsurgical outcome was stable.Concomitant device reported: radial head- part #09.402.024s/ lot # 9895703, quantity x 1.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation has been completed.The returned 04.402.007s titanium straight radial stem and 09.402.024s cocr radial head were reported to have been revised and explanted due to postoperative loosening.This complaint condition has been investigated and resulted in recall and the voluntary product removal of the radial head prosthesis system.Appropriate actions were taken to address the issue.X-rays were not provided and therefore this complaint cannot be confirmed.Results code utilized to capture x-rays were not provided and therefore this complaint cannot be confirmed.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 STRAIGHT RADIAL STEM 26MM-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: 6376275
• MDR Text Key: 69014411
• Report Number: 1719045-2017-10174
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 9895682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: 09.402.024S, 24MM COCR RAD HEAD STD HGT/13.0MM STL
• Patient Outcome(s): Required Intervention
• Patient Weight: 81