MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL ACTIVE ARTICULATION- HIP BEARING; PROSTHESIS, HIP

Catalog Number XL-200152

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05463.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product confirmed the complaint as the box and product did not match.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a manufacturing error.A summary of the investigation has been sent to the complainant.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 during a total hip arthroplasty, the acetabular liner inside the package did not match the label.Another liner was available to complete the procedure without patient injury or significant delay.

• Brand Name: ARCOMXL ACTIVE ARTICULATION- HIP BEARING
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6517154
• MDR Text Key: 73801722
• Report Number: 0001825034-2017-02784
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/24/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/13/2021
• Device Catalogue Number: XL-200152
• Device Lot Number: 339260
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1024-2017
• Patient Sequence Number: 1