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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age and weight not provided for reporting.Udi: (b)(4).Per additional information the explant date may be: (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.Facility tél.(b)(6).The devices were explanted and no new hardware was implanted.Device history records review was conducted.The report indicates that the: manufacturing location: supplier (b)(4), packaged by: (b)(4), manufacturing date: 08-may-2013, expiration date: 30-apr-2018, part #: 04.402.008s, lot#: 7013303 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 52.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.Scn no: 9342 ¿sterility documentation was reviewed and determined to be conforming.¿ article: 04.402.008/7013303 radial stem, uncemented, straight, size 8mm, l 28mm.09.402.024s/7529642 radial head 0 24mm, in cemented, standard height 13.0mm.Cause of investigation: loosening of the radial head prosthesis - removal surgery needed.Cause of failure: the investigation has confirmed that these implants are subjected to delivery stop ds2016615 and ds2016620 and the parts are consequently blocked in the sap system.In addition on 30 dec 2016 synthes (b)(4) has initiated a voluntary medical device removal (recall) of the depuy synthes radial head prosthesis system due to the possibility that the radial stem may loose post-operatively at the stem bone interface (fsn 555531).We have taken note of your input, this report has been registered in our market vigilance system and the corresponding statistical data will be kept under trending.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the surgeon mentioned he had a loosening of the radial head prosthesis.The radial head prosthesis was removed and no other implant was implanted.Information from surgery report: the implantation took place on (b)(6) 2017.Reason for second surgery performed on (b)(6) 2016 was unfortunate post-triad status of the left elbow with placement of a radial head prosthesis and aseptic unsealing of the lead radial head prosthesis.Patient outcome is that the implants are loose but he has no pain.This complaint involves 2 parts.This report is 1 of 2 for (b)(4).

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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 6405501
• MDR Text Key: 69995158
• Report Number: 1719045-2017-10212
• 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,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2017

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: 04/30/2018
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7013303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; 10/12/2017
• Supplement Dates FDA Received: 04/19/2017; 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• 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