MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD OPTION HEAD 36MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Metal Shedding Debris (1804); Malposition of Device (2616)

Patient Problems Cyst(s) (1800); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Discomfort (2330); Toxicity (2333); Disability (2371); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/30/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported that the patient underwent total right hip arthroplasty on (b)(6) 2009 and an initial total left hip arthroplasty on (b)(6) 2007.Patient's legal counsel further reported that a right hip revision procedure was performed on (b)(6) 2014 due to unknown reasons.The patient alleges pain, discomfort, inflammation, soreness, dysfunction, loss of range of motion, elevated metal ion levels, metal poisoning, metallosis, and lack of mobility.Four invoices were located for this patient during the invoice history review, confirming the initial left hip and right hip surgery dates and the right hip revision date.The fourth invoice reviewed indicates that the patient underwent an unknown procedure on an unknown side on (b)(6) 2014 wherein the modular head was removed and replaced.Additional information received in operative report noted patient underwent a right hip revision procedure on (b)(6) 2014 due to unspecified mechanical complications.During the procedure, a loose and malpositioned acetabular cup, metallosis, acetabular erosion and cyst formation were noted.The acetabular cup, modular head, and taper adapter were removed and replaced with a biomet head and taper adapter and a competitor cup and liner.Operative report noted patient underwent a further right hip revision procedure on (b)(6) 2014 due to instability.Operative report further noted seroma during the procedure.The modular head and competitor liner were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity." under warnings, it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 5 of 5 mdrs filed for the same event (reference 1825034-2015- 01488 / 01491 & 02400).

• Brand Name: CER BIOLOXD OPTION HEAD 36MM
• 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: 4815132
• MDR Text Key: 15840430
• Report Number: 0001825034-2015-02400
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 893970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2014
• 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
• Patient Age: 71 YR