MAUDE Adverse Event Report: SYNTHES MONUMENT 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.026S

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 january, 2018.A device history review was conducted.The report indicates that nemcomed (now known as avalign technologies-nemcomed) manufactured the 6mm ti curved radial stem, part #04.402.026 and lot #7012294 on po #(b)(4) delivered february 13, 2013 for (b)(4) parts processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated february 11, 2013 and was inspected and conformed to the synthes final inspection sheet (b)(4), revision ¿b.¿ the parts were labeled, packaged, sterilized (po # (b)(4)) at sterigenics (corona) and released to the warehouse on march 8, 2013, with expiration date january 2018.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: 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-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: 4485747
• MDR Text Key: 5570178
• Report Number: 2520274-2015-10747
• 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: 09.402.026S
• Device Lot Number: 7012294
• 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: 08/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1