MAUDE Adverse Event Report: ZIMMER INC UNKNOWN HUMERAL STEM ASSEMBLY; ELBOW PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that a revision surgery is scheduled for unknown reasons.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient has a revision surgery scheduled for a loose humeral component.

Manufacturer Narrative

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.Product history search cannot be completed since the part and lot number is unknown.Patient activity level and adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

Event Description

It is reported the patient was revised due to loosening of the humeral component.

• Brand Name: UNKNOWN HUMERAL 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: 5550896
• MDR Text Key: 41979221
• Report Number: 1822565-2016-00921
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2016

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?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2016; 08/25/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR