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

Catalog Number 00875305601

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.(b)(4).Other device used: catalog #00875305201, lot #62853506 catalog #00875201232, continuum, trilogy, allofit it polyethylene liner, lot #62693847 catalog #00875201032, continuum, trilogy, allofit it polyethylene liner, lot #62779370 this report will be amended when our investigation is complete.

Event Description

It is reported that the liner's size doesn't match with the appropriate acetabular component visually.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The poly liners and shells were returned for further review.Liner with lot 62693847 was returned assembled in shell (lot 62845683); however it was not seated flush with the shell.Dimensional measurements of the shells conformed to print specifications where measured.The liners were not dimensionally evaluated due to their returned condition.Debris was noted on the anti rotation tabs.Device history records for the lot codes associated with the shells and liners were reviewed.No deviations or anomalies were noted with the device history record review.The devices were 100% inspected and accepted by certified operator on a coordinate measuring machine, at the time of manufacture.The shells and liners are compatible combinations.The liner with lot 62693847 was dis-assembled from the shell (lot 62845683) and re-assembled.The functional test performed on all the 4 devices confirmed that the liners mated appropriately with the respective shells.Review of the complaint history indicated no prior complaints for the part-lot combinations for the liners and shells.A specific cause for the reported issue cannot be determined with the information provided.The reported devices are used for treatment.

• Brand Name: TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES
• Type of Device: LZO
• 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: 5027456
• MDR Text Key: 24549880
• Report Number: 1822565-2015-01577
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00875305601
• Device Lot Number: 62845683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2015; 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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 Age: 75 YR
• Patient Weight: 95