MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI METRIC COLLARLESS POROUS STEM- ALLIANCE X-SERIES; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Hip Fracture (2349)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 3 of 4 mdr's filed for the same patient (reference 1825034-2016-03959, 05393 / 05394, 05442).

Event Description

It was reported that during a hip revision procedure, the femoral head would not separate from the stem.When attempting to remove it, the patient experienced a proximal femoral fracture.The stem and head could not be separated, and were removed as one piece.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was confirmed through review of medical records.Operative report indicated the head could not be removed from the taper, resulting in a femoral fracture.Device history record was reviewed and no discrepancies were found.Root cause of the event could not be confirmed.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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: BI METRIC COLLARLESS POROUS STEM- ALLIANCE X-SERIES
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6216545
• MDR Text Key: 63686714
• Report Number: 0001825034-2016-05394
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: X180314
• Device Lot Number: 184880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2006
• 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
• Patient Age: 59 YR