MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X56MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Expiration Issue (1216)

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

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device was requested and was not returned by the hospital.Review of the dhr found deviations during manufacturing process, the nonconformance involved a unit that was scrapped during machine complete step.Review of the complaint history identified an issue that is being addressed by internal controls.Without the opportunity to complete the visual inspection of the device, the root cause could not be determined.The complaint was not confirmed.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Risks include"expired product usage." following review, no new risks were identified.(b)(4).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 the patient underwent an initial hip procedure and during the procedure an expired 56mm active articulating bearing was implanted.The device was removed and replaced with another available unit.No additional patient consequences were reported.

• Brand Name: ACT ARTIC E1 HIP BRG 28X56MM
• 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: 6983675
• MDR Text Key: 90995262
• Report Number: 0001825034-2016-02558
• Device Sequence Number: 1
• Product Code: KWY
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2017

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: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: EP-200162
• Device Lot Number: 149450
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2011
• 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: 67 YR