MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

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 1 of 2 for complaint (b)(4).This report is for an unknown radial head.

Manufacturer Narrative

Device is used for treatment, not diagnosis.This report is for one radial head, 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).A device history review was conducted.The report indicates that nemcomed (now known as avalign technologies-nemcomed) manufactured the 24mm cocr radial head std ht/13mm, part #09.402.024 and lot #6905448 on po #(b)(4) delivered november 12, 2012 for (b)(4) parts processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated november 7, 2012 and was inspected and conformed to the synthes final inspection sheet (b)(4), revision ¿a.¿ the parts were labeled, packaged, sterilized (po # (b)(4)) at sterigenics (corona) and released to the warehouse on december 10, 2012, with expiration date october 31, 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: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-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: 4485692
• MDR Text Key: 5348451
• Report Number: 2520274-2015-10734
• 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 Expiration Date: 10/31/2017
• Device Catalogue Number: 09.402.024S
• Device Lot Number: 6905448
• 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: 12/10/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1