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

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

The following could not be completed with the limited information provided.Initial reporter - ni.

Event Description

It is reported that the patient's hip arthroplasty was revised one month post op due to disassociation of the acetabular liner.

Manufacturer Narrative

This follow up report is being filed to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow up report is being filed to relay corrected, updated and additional information.This information does not change the previously submitted investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TRILOGY SHELL WITH CLUSTER HOLES
• Type of Device: PROSTHESIS, HIP
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6376973
• MDR Text Key: 69034753
• Report Number: 0001822565-2017-01477
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 65875305801
• Device Lot Number: 62739207
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• 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
• Treatment: ITEM#00811400230, CPT STEM, LOT#62722830
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR