MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRILOGY ALLOFIT VIVACIT-E ELEVATED RIM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Report source, foreign ¿ event occurred in (b)(6).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.

Event Description

It was reported that the liner would not assemble with the shell.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation identified no witness marks or signs of damage.Dimensional analysis determined that all dimensions were conforming to the print specifications.No other anomaly was noted.Review of the device history records for the reported liner identified no deviations or anomalies that could contribute to the reported event.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: CONTINUUM TRILOGY ALLOFIT VIVACIT-E ELEVATED RIM LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6894059
• MDR Text Key: 87730601
• Report Number: 0001822565-2017-06509
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK120370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

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: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00885200932
• Device Lot Number: 63494534
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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