MAUDE Adverse Event Report: ZIMMER INC TRILOGY LONGEVITY CROSSLINKED LINER; LPH

Catalog Number 00630505632

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported a patient was revised due to broken liner.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Concomitant products: 00620005622, shell porous with cluster holes, lot #60190587; item #unk, unknown mayo stem, lot #unk; item #00642803201, alumina ceramic femoral head, lot #unk.Complaint sample was evaluated and the reported event was confirmed, as the liner was fractured and gouged.Device history records were reviewed and no discrepancies were found.It is unknown whether the components were implanted with the correct fit, orientation or compatibility as per the surgical technique.The device remained in-vivo for 10 years and 6 months.Relevant medical history and adherence to rehabilitation protocol are unknown.A definitive root cause cannot be determined with the information provided.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.

Event Description

It is reported a patient was revised due to a broken polyethylene liner approximately 10 years post-implantation.During the procedure, the liner and femoral head were removed and replaced.Attempts to obtain additional information have been made; however, no more information is available.

• Brand Name: TRILOGY LONGEVITY CROSSLINKED LINER
• 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: 5315601
• MDR Text Key: 34030729
• Report Number: 1822565-2015-02704
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK990135
• 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,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2007
• Device Catalogue Number: 00630505632
• Device Lot Number: 56131700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/11/2016; 04/07/2016; 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2002
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 99