MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.027S

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported on an unknown date, postoperative x-rays revealed radial head prosthesis loosening.No other information available.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 one 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

Additional narrative: additional patient identifier: (b)(6).Expiration date reported as november 2017.A device history review was conducted.The report indicates that nemcomed (now known as avalign technologies-nemcomed) manufactured the 7mm ti curved radial stem, part #04.402.027 and lot #7012309 on po #(b)(4) for (b)(4) parts delivered on november 21, 2012 and processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated november 16, 2012 and was inspected and conformed to synthes final inspection sheet (b)(4), revision ¿b.¿ the parts were labeled (8 parts were split to lot #7123555 for processing on work order (b)(4) at labeling), packaged, sterilized (po #(b)(4)) at (b)(4) and released to the warehouse on january 3, 2013, with expiration date november 2017.There were no mrr¿s, ncr¿s, 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: 7MM TI CURVED RADIAL STEM 42MM-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: 4485718
• MDR Text Key: 5330506
• Report Number: 2520274-2015-10735
• 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: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7012309
• 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: 01/03/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1