MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM SHELL TM SHELL WITH CLUSTER HOLES

Catalog Number 00875705001

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It is reported that pt is experiencing pain and possible loosening of the acetabular component.

Manufacturer Narrative

Surgical notes stated that the tha was for right hip degenerative joint disease.This was the second hip revision at this time for the pt.The acetabular shell was slightly retroverted during the trial range of motion.The shell was removed and repositioned.The final tha reduction was found to be stable in all physiologic positions.No complication noted.Post operative notes stated that the pt was having pain typically over the right groin.During the range of motion eval, the slight groin pain was noted on the right extremes of coupled flexion and internal rotation or extreme abduction.X-ray comparison over the last 3 years showed that the acetabular component had shifted a few degrees vertically.No windshield wiper ring around screws was noted and no significant radiolucent lines shown.The surgeon thinks that the acetabular shell may have fibrous in-growth instead of bony in-growth, which may lead to micro-motion in certain activities.With the info provided, a definitive root cause cannot be determined.Mfg records were reviewed and found to be conforming to the requirements at the time of manufacture.

• Brand Name: CONTINUUM SHELL TM SHELL WITH CLUSTER HOLES
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4691876
• MDR Text Key: 5650613
• Report Number: 1822565-2015-00537
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 00875705001
• Device Lot Number: 61700901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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): Other
• Patient Weight: 64