MAUDE Adverse Event Report: ZIMMER, TRILOGY BONE SCREW

Catalog Number 00625006560

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

It is reported that during surgery, the screw pulled through the shell when it was being screwed into the bone.The screw was left in place.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: TRILOGY BONE SCREW
• Manufacturer (Section D): ZIMMER,; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita 00715
• Manufacturer Contact: kevin escapule ; p.o box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4262314
• MDR Text Key: 5104565
• Report Number: 2648920-2014-00302
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2018
• Device Catalogue Number: 00625006560
• Device Lot Number: 61063127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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
• Treatment: LOT #61985536 MANUFACTURED BY ZIMMER INC.(B)(4); ZIMMER TM MODULAR CUP, CATALOG #00620205420