MAUDE Adverse Event Report: ZIMMER INC UNKNOWN COONRAD/MORREY HUMERAL 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 the patient experienced loosening with moderate pain.

Manufacturer Narrative

(b)(4).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 ¿one humeral component with inadequate cementation was found to be loose 4 years postoperatively¿.Follow up communication with the field and the article indicates that ¿an anterograde cementing technique was used with direct injection of the cement with a syringe, contrary to the recommendations of the manufacturer, which advises the use of an injecting system with retrograde insertion of the cement.¿ the follow up communication also states that the ¿early loosening 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 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: 5486710
• MDR Text Key: 39927030
• Report Number: 1822565-2016-00590
• 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

• Date FDA Received: 03/08/2016
• 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: 06/23/2016
• 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: 66 YR