MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD 4MM HT EXTENSION/16.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.420S

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head/unknown lot.Devices have not been reported as explanted.Without a lot number the device history records review could not be completed.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 a female patient who received a radial head prosthesis on an unknown date is complaining of pain at the surgical site.It was reported that the devices were confirmed as synthes on x-ray.The area is fully healed, the construct is stable and the patient has full range of motion.The surgeon was attempting to rule out an allergic reaction to the device material versus symptomatic hardware.She was sent to an allergist for skin testing.This report is for an unknown radial head.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device scheduled for explant in early (b)(6) 2015; has not been reported if the device has been explanted yet.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

The patient is scheduled for a revision radial head replacement surgery in early (b)(6) 2015; it has not been reported if that procedure has occurred yet.

Manufacturer Narrative

Udi: ((b)(4).\device history record (dhr) review: part #: 09.402.420s, lot#: 7607095 (sterile) - 20mm cocr radial head 4mm ht extension/16.0mm-sterile - 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.¿sterility documentation was reviewed and determined to be conforming.¿ 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 underwent revision surgery on (b)(6) 2015 due to loosening of implants and nonunion.The patient was revised with synthes devices which included using a longer radial stem along with a slightly larger radial head.Devices were explanted and were fully in tact.Surgery was successfully completed without any delays or harm to patient.

• Brand Name: 20MM COCR RADIAL HEAD 4MM HT EXTENSION/16.0MM-STER
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5214717
• MDR Text Key: 30967865
• Report Number: 2520274-2015-17184
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 09.402.420S
• Device Lot Number: 7607095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 53