MAUDE Adverse Event Report: SYNTHES MONUMENT TI HUMERAL STEM PRESS-FIT SIZE 8/120MM-STERILE

Catalog Number 5537-8/12

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Impaired Healing (2378); Cusp Tear (2656); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

It was reported that a revision surgery and hardware explant of an epoca shoulder arthroplasty system was performed due to nonunion of the patients greater tuberosity, limited external rotation and inability to lift the implanted arm past 30 degrees.The surgeon originally performed a tuberosity of the shoulder and implanted the patient with the epcoa shoulder arthroplasty system on (b)(6) 2013.During a post-operative exam in early (b)(6), the patient presented with limited external rotation and the inability to lift the implanted arm past 30 degrees.Imaging was performed, and the patient was diagnosed with nonunion of the greater tuberosity of the humerus and was diagnosed with cuff tear arthropathy.The patient was revised to a reverse total shoulder system (manufacturer unknown) on (b)(6) 2014.The surgery was successfully completed.The revision was reportedly not due to a device related issue concerning the epoca shoulder arthroplasty system products.This is report 4 of 5 for file (b)(4).

Manufacturer Narrative

This device is intended for treatment, not diagnosis.(b)(6).Additional product codes include mbf, hsd.A review of the device history records was performed and no complaint related issues were found.The investigation could not be completed and no conclusion could be drawn as no product was received for evaluation.Placeholder.

• Brand Name: TI HUMERAL STEM PRESS-FIT SIZE 8/120MM-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: danielle fazio ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3606101
• MDR Text Key: 4094815
• Report Number: 1719045-2014-00037
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5537-8/12
• Device Lot Number: 6364445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72