MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 9X125MM 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); Patient Problem/Medical Problem (2688)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: 010000664 ¿ g7 shell ¿ 662979, 010000858 ¿ g7 neutral liner ¿ 6623312, 12-115120 ¿ ceramic head ¿ 2986013. Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product 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 - 2020 - 01627. 0001825034 - 2020 - 01628.

Event Description

It was reported that patient experienced delayed would healing and draining approximately 1 month post initial right total hip arthroplasty. Approximately 3 weeks later, a superficial irrigation and debridement was performed for would dehiscence. The outcome is pending. No revision of devices has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ECHO POR FMRL LAT NC 9X125MM
• 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: 9952960
• MDR Text Key: 187399503
• Report Number: 0001825034-2020-01629
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304463325
• UDI-Public: (01)00880304463325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 192109
• Device Lot Number: 925910
• 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: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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 Treatment Data

Date Received: 04/13/2020 Patient Sequence Number: 1