MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X54MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Fitting Problem (2183); Device-Device Incompatibility (2919)

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

Event Date 10/06/2014

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This complaint cannot be confirmed.The returned part was reviewed visually and features relevant to the complaint were measured.And although one dimension was found to be out of specification it is determined to be the result of multiple attempts at assembly.This part is believed to have been conforming when it left biomet.Review of device history records found these units were released to distribution with an unrelated deviation or anomaly.Review of complaint history found no additional related issues for this item.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during a total hip arthroplasty on an unknown side, when compressing the cup with liner on the head,it would not stay connected.When practicing range of motion, it would continue to pop off.The surgeon requested a new liner.The same size liner was used to complete the procedure.

• Brand Name: ACT ARTIC E1 HIP BRG 28X54MM
• 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: 6958281
• MDR Text Key: 90519487
• Report Number: 0001825034-2017-08824
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2017

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 Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-200160
• Device Lot Number: 719750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• 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