MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRILOGY IT ACETABULAR SHELL WITH CLUSTER HOLES; HIP PROSTHESIS

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 10/30/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).

Event Description

It is reported that the acetabular cup became disassociated with the implant inserter, and the blocker in the cup couldn¿t be taken out.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported issue and should not be reported.The initial report should be voided.

• Brand Name: ZIMMER TRILOGY IT ACETABULAR SHELL WITH CLUSTER HOLES
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6128499
• MDR Text Key: 60933500
• Report Number: 0001822565-2016-04352
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK091508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

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 Model Number: N/A
• Device Catalogue Number: 00875305201
• Device Lot Number: 63159292
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; 04/16/2018
• Supplement Dates FDA Received: 01/11/2017; 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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 Age: 48 YR
• Patient Weight: 75