MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FREEDOM STD FACE LINER SZ 25; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity." additional event for this patient reported on medwatch numbers 1825034-2016-02668 / 02669.

Event Description

Patient underwent a left hip revision procedure four days post-implantation due to dissassociation of the liner from the cup.The liner, locking ring, and modular head were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-02666 & 03475).

Event Description

Patient underwent a left hip revision procedure four days post-implantation due to dissassociation of the acetabular liner from the cup.It was further reported that the choice of locking ring that was initially implanted may have contributed to the disassociation.The liner, locking ring, and modular head were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

• Brand Name: FREEDOM STD FACE LINER SZ 25
• Type of Device: PROSTHESIS, HIP
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5810587
• MDR Text Key: 50059522
• Report Number: 0001825034-2016-02666
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-107324
• Device Lot Number: 299340
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/02/2016; 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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: 79 YR