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 Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported on an unknown date postoperative x-rays revealed radial head prosthesis loosening.This is report 2 of 2 for complaint (b)(4).This report is for an unknown radial stem.

Manufacturer Narrative

Device is used for treatment, not diagnosis.This report is for a radial stem, catalog and lot numbers unknown.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records was completed: nemcomed (now known as avalign technologies-nemcomed) manufactured the 8mm ti straight radial stem, part 04.402.008 and lot 7012217.Initially, the part conformed to the supplier¿s certificate of conformance and was inspected and conformed to the synthes final inspection sheet.The parts were labeled, packaged, sterilized at sterigenics ((b)(4)) and released to the warehouse on december 12, 2012, with expiration date october 2017.There were no material review reports, non-conformance reports, or complaint related issues with this lot.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: 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: 4476997
• MDR Text Key: 20122483
• Report Number: 2520274-2015-10716
• 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,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• 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: 02/05/2015
• 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