MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 05/14/2015

Event Type  Injury  

Manufacturer Narrative

The product was returned for evaluation and the event was not confirmed.Visual and radiographic inspection identified a fractured ceramic head and scratches and damage on the liner.The failure of the implant was due to fracture of the ceramic head.Although the exact cause cannot be identified with the information provided, it is unknown if debris was present at the taper interface during head impaction or that the head was not seated correctly upon the taper, which resulted in higher stresses and the eventual fracture of the head.Review of the dhr and complaint history found no anomalies or adverse trends.The root cause was attributed to surgical technique, patient condition and implant overload.A summary of the investigation has been sent to the complainant.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under "possible adverse effects," fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight.Following review, no new risks were identified.(b)(4).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.This report is being submitted late as it has been identified in remediation.(b)(4).

Event Description

It was reported that the patient had an initial hip procedure on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to a fractured ceramic head.The head and liner were revised.No foreign bodies were retained by the patient.

• Brand Name: G7 HI-WALL E1 LINER 32MM F
• 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: 6959368
• MDR Text Key: 89683765
• Report Number: 0001825034-2017-08988
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000928
• Device Lot Number: 3387310
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• 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; Required Intervention