MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY SHELL WITH CLUSTER HOLES; HIP PROSTHESIS

Catalog Number 00620006022

Device Problems Bent (1059); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the trilogy cup locking ring came out during a liner insertion.The surgeon tried to rethread it, but it was bent and would not rethread.The doctor had to remove the cup and replace it with a new trilogy cup.There was a reported 20 minute delay in surgery and surgery was completed with another device.

Manufacturer Narrative

Reported event was unable to be confirmed.A 60mm fiber metal shell and a poly liner were returned for review.As returned, the lock ring is deformed and no longer in the lock ring groove of the shell.Damage is seen on the inner diameter of the shell.The poly liner exhibits damage to the outside diameter.Damage is too severe to measure the liner.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.With the information provided, a specific cause could not be determined for the reported condition.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.

Manufacturer Narrative

A summary of the investigation is being sent to the complainant conveying proper surgical technique and use of the device.

• Brand Name: TRILOGY SHELL WITH CLUSTER HOLES
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5940468
• MDR Text Key: 54401392
• Report Number: 0002648920-2016-03158
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 00620006022
• Device Lot Number: 62675102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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
• Patient Age: 83 YR