MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 9X125MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/16/2022

Event Type  Injury  

Event Description

It was reported the patient underwent a left hip revision approximately 1 month post implantation due to a closed nondisplaced oblique fracture of left femur from a mechanical fall.No additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed due to the review of medical records.Medical records were not provided for the revision that occurred on (b)(6) 2022.Medical notes for the initial procedure state a lateral femoral cortical perforation occurred.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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.

• Brand Name: ECHO POR FMRL 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: 13568081
• MDR Text Key: 287589260
• Report Number: 0001825034-2022-00375
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260407
• UDI-Public: (01)00887868260407(17)310304(10)735450
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192009
• Device Lot Number: 735450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic