MAUDE Adverse Event Report: ZIMMER INC TRILOGY ACETABULAR CLUSTER SHELL WITH HOLES; LPH

Catalog Number 65620005622

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the surgeon had issues with engaging the trilogy polyethylene liner into the shell.After removing the liner from the shell the surgeon tried to rotate the locking ring within the shell.It wasn't possible to rotate it, the surgeon noticed that the ring had some kind of impingement.As a result the locking ring wouldn't open enough to accommodate the liner.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Reported event was unable to be confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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.

• Brand Name: TRILOGY ACETABULAR CLUSTER SHELL WITH HOLES
• Type of Device: LPH
• 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: 5410308
• MDR Text Key: 37716407
• Report Number: 1822565-2016-00197
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 65620005622
• Device Lot Number: 62980988
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Required Intervention