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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that one patient experienced loosening with severe pain.

Manufacturer Narrative

This report is being amended to reflect changes.No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is 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 the ¿patient had a loose ulnar component 3 years postoperatively that was attributed to coronoid impingement¿.The article also notes that ¿impingement between the anterior flange of the humeral component and the coronoid process was considered to be a possible cause of ulnar loosening in 1 patient.Such an impingement limits flexion and results in distraction forces between the ulnar component and the proximal ulna¿.The patient had (b)(6) procedures prior to this (b)(6) total elbow arthroplasty.Follow up communication with the field indicates that "the early loosing described in the article were all related to the anterograde cementing technique which did not correspond to the recommended injecting system with retrograde insertion".Product history search cannot be completed and the compatibility cannot be verified since the part and lot number is unknown.Patient activity level and adherence to rehabilitation protocol is unknown.The bone cement information is unknown and therefore manufacturer¿s cementing technique cannot be compared with the cementing technique given in the article.A definite root cause for the loosening cannot be determined with the information provided.

• Brand Name: UNKNOWN COONRAD/MORREY ULNAR STEM 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: 5467568
• MDR Text Key: 39271467
• Report Number: 1822565-2016-00415
• 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: 02/03/2016

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/29/2016
• 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): Other
• Patient Age: 55 YR