MAUDE Adverse Event Report: ZIMMER, INC. NEXEL TOTAL ELBOW ULNAR STEM; ELBOW PROSTHESIS

Catalog Number 00840001407

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown.Review of the device history records did not find any deviations or anomalies.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.Product history search revealed no other complaints for infection for the related part and lot combinations.Patient¿s activity level and adherence to rehabilitation protocol is unknown.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused or contributed to any patient infection.A definite root cause cannot be determined with the information provided.

Event Description

It is reported the patient underwent a two-stage revision for infection; the first state occurring on (b)(6) 2015 and the second stage occurring on (b)(6) 2016.

• Brand Name: NEXEL TOTAL ELBOW ULNAR STEM
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5864620
• MDR Text Key: 51728344
• Report Number: 0001822565-2016-02763
• 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: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

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
• Device Catalogue Number: 00840001407
• Device Lot Number: 63000890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention