MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. Year of birth: (b)(6). Concomitant medical products: item number: 163668, item name: 32 mm mod femoral head, item lot: j6138153; item number: 010000662, item name: g7 acetabular shell, item lot: 6161079; item number: 010000848, item name: g7 neutral e1 liner, item lot: 3606652. Foreign report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03857; 0001825034 - 2019 - 03858; 0001825034 - 2019 - 03859. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient experienced delayed wound healing approximately nine days post-implantation. Patient required two hip aspirations. No additional intervention was required, reports note that the wound concerns were resolved approximately one month post-implantation. No additional information is available at this time.

• Brand Name: ECHO POR FMRL LAT NC 12X140MM
• 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: 8946621
• MDR Text Key: 156020579
• Report Number: 0001825034-2019-03856
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 192112
• Device Lot Number: 911630
• 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: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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: 08/29/2019 Patient Sequence Number: 1