MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Date of birth: (b)(6). Concomitant medical products: catalog#: ep-200144 act artic e1 hip brg 28x38mm lot#: 645000, catalog#: 110010242 g7 osseoti 3 hole shell 48mm c lot#: 6564825, catalog#: 110024461 g7 dual mobility liner 38mm c lot#: 475980, unknown stem. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04861, 0001825034-2019-04866, 0001825034-2019-04868, 0001825034-2019-04869.

Event Description

It was reported that the patient underwent a wash out of the wound approximately one month post implantation. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ARCOS CON SZ A STD 50MM
• 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: 9247704
• MDR Text Key: 164106306
• Report Number: 0001825034-2019-04867
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 11-301300
• Device Lot Number: 023440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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: 10/28/2019 Patient Sequence Number: 1