MAUDE Adverse Event Report: ZIMMER INC UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY; ELBOW PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Sciencedirect.Com/science/article/pii/s1058274606000851 (b)(4).Other devices used: catalog #unknown, unknown coonrad/morrey ulnar stem assembly, lot #unknown.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to mild pain and a triceps rupture.

Manufacturer Narrative

This report is being amended to reflect changes.No devices or photos were received; therefore the condition of the components is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.These devices are used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It is noted in the article that ¿patients in whom the (b)(6) triceps-reflecting approach was used had a triceps rupture¿.It was also noted in the article that the ¿patient required triceps repair resulting in improved extension strength of m4 according to the medical research council¿.Follow up communication with the field indicates that the reported issue is not related to the product itself.Product history search cannot be completed and the compatibility cannot be verified since the part and lot numbers are unknown.Patient activity level and adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5486202
• MDR Text Key: 39879772
• Report Number: 1822565-2016-00594
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR