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

Catalog Number 65620005420

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem No Information (3190)

Event Date 10/27/2014

Event Type  Injury  

Event Description

It is reported the patient was revised due to acetabular loosening.During the surgery, a broken screw was explanted.

Manufacturer Narrative

This report wil be amended when our investigation is complete.

Manufacturer Narrative

The devices were not returned, therefore their conditions cannot be described.Manufacturing documentation was reviewed and found conforming to specifications, with no anomalies or deviations found.These devices were used in the treatment of a medical condition.The devices were in-vivo for 11 years at the time of revision.Primary operative notes were reviewed and state that there was a cavitary lesion in the acetabulum which was filled with bone graft before impaction of the acetabular cup.Two screws were used for fixation with no issues noted.The preoperative diagnosis for this procedure was posttraumatic hip arthritis with acetabular fracture.Revision operative notes appear to convey that the patient additionally had multiple pieces of hardware in her hip, one of which was loose, including two plats, a solid screw and a cannulated screw.These devices were likely the result of the patient's previous acetabular fracture which was treated with internal fixation.The patient is additionally morbidly obese with a bmi of 50.No additional complaints have been received against the devices related to this complaint.It cannot be determined if and/or how the other hardware within the hip contributed to the described event.

• Brand Name: TRILOGY SHELL WITH CLUSTER HOLES
• 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: 4877624
• MDR Text Key: 5867199
• Report Number: 1822565-2015-01007
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2006
• Device Catalogue Number: 65620005420
• Device Lot Number: 75197200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MANUFACTURED BY (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR