MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 13X145MM PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). D. O. B: unknown month and day in (b)(6). Concomitant medical devices: catalog#: 010000663 g7 pps ltd acet shell 52e lot#: 6320647; catalog#: 650-1162 delta cer fem hd 32/0mm t1 lot#: 2018080547; catalog#: 110003626 biolox delta cer lnr 32mm e lot#: 3745537. Foreign: (b)(6). At this time, it is unknown if the device will be returned for evaluation, due to location of device is unknown; however, an investigation of the reported event is in progress. 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: 0001825034-2021-00352.

Event Description

It was reported that approximately one month post implantation, the patient experienced a superficial skin infection. The infection was resolved with medication. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ECHO POR FMRL LAT NC 13X145MM
• 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: 11280832
• MDR Text Key: 230460099
• Report Number: 0001825034-2021-00351
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 192113
• Device Lot Number: 147410
• 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: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 02/04/2021 Patient Sequence Number: 1