MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

Catalog Number 04.402.008S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported there was an adverse event with the 8 mm titanium straight radial stem (lot number 7012222) and 24 mm cobalt chromium (cocr) radial head (lot number 6892442).The devices were implanted on (b)(6) 2013 with no issues.The patient came back in with an infection on (b)(6) 2014.It was reported that the patient had a history of (b)(6) and did not inform the doctors so the patient was treated with the incorrect antibiotic after surgery, causing the infection.Devices were explanted on (b)(6) 2014.During the explant, it was discovered that the devices were loose.The patient was treated with irrigation and debridement of the infection site.The patient was treated with a different antibiotic and the wound was closed.There are no plans for reimplantation at this time.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.Placeholder.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: w. lindenmuth ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3586266
• MDR Text Key: 4165288
• Report Number: 1719045-2014-00031
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7012222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80