MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZMR PROXIMAL CONE BODY; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): unknown head-unknown; unknown liner-unknown; unknown cup-unknown; unknown zmr 19 mm-unknown.Medical records were not provided.The patient's x-rays were reviewed in the emergency room and the surgeon concluded there was no evidence of hardware failure and was discharged with a diagnosis of hip strain.However, the x-rays actually demonstrated an un displaced fracture of the trunnion of the femoral stem that was not noticed by the surgeon.The patient returned home, attempted to walk with crutches, and fell.Upon returning to the er, the x-rays showed a catastrophic failure of the femoral component with a fracture at the junction of the head and stem, i.E., a fracture at the trunnion which had been un displaced but identifiable at the time the x-rays were first reviewed earlier that day.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.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.

Event Description

It was reported patient underwent a revision procedure approximately two years post-implantation due to a fracture of the femoral component at the junction of the head.Patient had fallen and x-rays showed a fracture of the femoral component at the junction of the head.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN ZMR PROXIMAL CONE BODY
• 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: 10663447
• MDR Text Key: 211011369
• Report Number: 0001822565-2020-03477
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention