MAUDE Adverse Event Report: ZIMMER INC CONTINUUM TM SHELL WITH CLUSTER HOLES; LZO

Catalog Number 00875705201

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 01/22/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to loose acetabular component and pain.

Manufacturer Narrative

No device 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.This device is used for treatment.Review of the operative notes dated (b)(6) 2012 confirms that the patient underwent revision right total hip arthroplasty due to aseptic loosening of competitor's right acetabular component.No complications noted.Operative notes dated (b)(6) 2015 has a brief clinical note which states that the acetabular "cup appeared to be migrating over time and on most of the recent films actually was starting to migrate into a more vertical position subluxating from the acetabulum with the two screws acting as fulcrum.It was noted in the operative notes that there was gross movement of the acetabular component.A single screw technique was used to remove the liner and then two screws, and the cup was easily extracted.The shell was in-vivo for 2 years 5 months.Patient activity level and adherence to rehabilitation protocol is unknown.A definitive root cause cannot be determined with the information provided.

• Brand Name: CONTINUUM TM SHELL WITH CLUSTER HOLES
• Type of Device: LZO
• 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: 5250357
• MDR Text Key: 32132283
• Report Number: 1822565-2015-02475
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 00875705201
• Device Lot Number: 62076008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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): Required Intervention
• Patient Age: 48 YR