MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 40MM +3 MAXROM LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 08/18/2015

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 11 states, ¿wear and/or deformation of articulating surfaces.¿ 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.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6), 2011.Subsequently, patient was revised on (b)(6), 2015 due to poly wear.It was further reported that the modular head wore through the poly liner causing a squeaky noise in the hip.The modular head, polyethylene liner, and locking ring 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.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.The impingement is likely what caused the fracture, not the wear.However, cause of the fracture cannot be determined this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03900 / 03901).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: E-POLY 40MM +3 MAXROM LNR SZ24
• 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: 5068756
• MDR Text Key: 25460067
• Report Number: 0001825034-2015-03901
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: EP-108424
• Device Lot Number: 990900
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• 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: 66 YR