MAUDE Adverse Event Report: ZIMMER INC TRILOGY ACETABULAR OBLIQUE LINER; LPH

Catalog Number 00615205632

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other device used, catalog #00620005622, trilogy shell with cluster holes, lot #60330573 manufactured by zimmer (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to wear.The surgeon believed the patient was going to dislocate without a revision.

Manufacturer Narrative

This report is being amended to reflect changes in sections.Visual inspection of the returned oblique liner found that the liner was damaged, had gouges and a fracture on the "elevated" section of the liner rim.The liner was not dimensionally evaluated as it was damaged.Visual inspection of the returned trilogy shell found bone growth on the shell.The shell also met the print specifications where measured.The device history records were reviewed for the related lots and found that the devices have been manufactured, inspected, sterilized and packaged in accordance to the zimmer quality procedures at the time of manufacture.These devices are used for treatment a product history search was completed and found no similar complaints for the related part and lot number combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.The package insert, states "fatigue fracture" is an adverse effect.This is therefore a known inherent risk of the procedure.A definitive root cause cannot be determined with the information provided.The complaint may be revised upon return of substantial information.

• Brand Name: TRILOGY ACETABULAR OBLIQUE 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: 5324558
• MDR Text Key: 34279415
• Report Number: 1822565-2015-02729
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00615205632
• Device Lot Number: 51717900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention