MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X150MM SPL TPR DIST PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Blood Loss (2597)

Event Date 02/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02857, 0001825034 - 2018 - 02859. Concomitant medical products: 11-301300 arcos con sz a std 50mm lot 712270, 11-363660 36mm cocr mod hd -6mm lot 279730. Reported event was confirmed with review of medical records received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined. 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. Not returned to manufacturer.

Event Description

It was reported that there was wound dehiscence with uncontrolled bleeding. Attempts have been made and no further information has been made available at this time.

• Brand Name: ARCOS 18X150MM SPL TPR DIST
• 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: 7448421
• MDR Text Key: 106137221
• Report Number: 0001825034-2018-02858
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 11-300818
• Device Lot Number: 140030
• Other Device ID Number: (01) 00880304474147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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 Treatment Data

Date Received: 04/20/2018 Patient Sequence Number: 1