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

Catalog Number 00620006020

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported when the shell was opened it was found to be missing the locking ring.

Manufacturer Narrative

(b)(4).The product with the missing locking ring was not returned and the related photos were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: TRILOGY ACETABULAR SHELL WITH 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5921075
• MDR Text Key: 53700671
• Report Number: 0001822565-2016-03058
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00620006020
• Device Lot Number: 63344884
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2016
• 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: 62 YR