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 Loose or Intermittent Connection (1371)

Patient Problems Irritation (1941); Pain (1994)

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision surgery on radial head prosthesis.The original implant was (b)(6) 2014.The components were loose and a revision was performed.The patient experienced an irritation, at an unspecified location.On (b)(6) 2014 the surgeon implanted a radial head prothesis stem size 8mm straight and 22mm cocr radial head size 22mm standard height.The patient complained of pain, x-ray showed possible loosening of the implant and it was decided to revise the implant.The implant was removed and revised using a longer stem and head.There was no surgical delay, the surgery was completed.This complaint involves three devices.This is 1 of 3 reports for (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.Expy-october 2017.A review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The part was not returned for evaluation.No conclusion could be drawn, as the part was not received.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4335828
• MDR Text Key: 22026010
• Report Number: 1719045-2014-10685
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7012217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR