MAUDE Adverse Event Report: SYNTHES USA; COCR HUMERAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/29/2014

Event Type  Injury  

Event Description

This reports is being filed after the subsequent review of the following article: andre´s-cano, p; et al (2015) results of uncemented hemiarthroplasty as primary treatment of severe proximal humerus fractures in the elderly.Eur j orthop surg traumatol 25, 273¿280.The purpose of this study was to analyze functional and radiologic results of a consecutive series of elderly patients who underwent uncemented hemiarthroplasty as primary treatment of complex proximal humeral fractures.Between 2009 and 2010, 21 consecutive patients with severe proximal humerus fracture and an indication for surgery (fractures with three or four fragments, head-splitting affecting more than 40% of the articular surface, and some fracture dislocations) were treated by performing an uncemented hemiarthroplasty with the epoca shoulder arthroplasty system (synthes, (b)(4)).At the end of the follow-up, ten patients had no symptoms in the affected shoulder, whereas seven had slight occasional pain, but did not require analgesics.Four patients had more frequent and severe pain.The radiograph clearly showed consolidation of the tuberosities in 15 cases, non-union in one and reabsorption in five.This is 7 of 12 for (b)(4).This report refers to an unknown epoca shoulder arthroplasty for patient 11, a 66 year-old female who experienced a serious injury pain.

Manufacturer Narrative

Device used for treatment, not for diagnosis.This report is for an unknown (prosthesis/unknown quantity/unknown lot.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: COCR HUMERAL STEM
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4704200
• MDR Text Key: 5725638
• Report Number: 2520274-2015-13013
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR