MAUDE Adverse Event Report: ZIMMER, INC. DISTAL CENTRALIZER; HIP PROSTHESIS

Catalog Number 00785901500

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 05/25/2009

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient had a surgery to take care of a hematoma that had developed.Within a few weeks following this surgery, the patient was revised due to an infection.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined that this device is not reportable as it was not involved in the event and did not malfunction.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DISTAL CENTRALIZER
• Type of Device: HIP 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: 5933059
• MDR Text Key: 54085082
• Report Number: 0001822565-2016-03160
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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 Expiration Date: 07/31/2018
• Device Catalogue Number: 00785901500
• Device Lot Number: 07888662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 58