MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ACT ARTIC E1 HIP BRG 28X46MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Separation (1562); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/30/2014

Event Type  Injury  

Event Description

It was reported patient underwent an initial total hip arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to dislocation and instability.When the patient was opened, the poly and head had separated.The modular head and bearing were removed and replaced.A longer neck was utilized in the revision.

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, it states: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00300/ -00301).

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.Product return date is feb 9, 2015.There is no indication with the information available that there was any non-conformance with the component as manufactured.The likely cause is something external to the function of the implant whereby the conditions of use caused or contributed to this event.

• Brand Name: ACT ARTIC E1 HIP BRG 28X46MM
• 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: 4447603
• MDR Text Key: 5386586
• Report Number: 0001825034-2015-00300
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

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: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-200152
• Device Lot Number: 770480
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 01/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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