MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ACTIVE ARTICULATION HIP SYSTEM DUAL MOBILITY BEARING ARCOM XL; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Code Available (3191)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Operation time extended.

Event Description

It was reported that the acetabular liner inside the package did not match the label.The procedure was completed with another available device, causing a delay of 45 minutes.

Manufacturer Narrative

Reported event was confirmed by review of pictures.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause of the reported issue is attributed to a manufacturing deficiency.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: ACTIVE ARTICULATION HIP SYSTEM DUAL MOBILITY BEARING ARCOM XL
• 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: 6228729
• MDR Text Key: 64046030
• Report Number: 0001825034-2016-05398
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/13/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-200152
• Device Lot Number: 339260
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: 12/09/2017
• Supplement Dates FDA Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other