MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-METRIC/X POR NC 12X140; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 11/22/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a left total hip arthroplasty on (b)(6) 2004.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2011 due to patient allegations of pain, discomfort, soreness, dysfunction, loss of range of motion and elevated metal ion levels.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in patient medical records revealed the revision was performed on (b)(6) 2011 due to pain, elevated metal ion levels, and squeaking.The patient¿s operative report noted gray-colored fluid, metallosis, fibrotic tissue; aseptic loosening of stem; and no significant bony ingrowth in proximal portion of the stem.

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2014-06747 / 06748 and 08751).

• Brand Name: BI-METRIC/X POR NC 12X140
• 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: 4275349
• MDR Text Key: 20070485
• Report Number: 0001825034-2014-08752
• 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: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/04/2014

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: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: X180312
• Device Lot Number: 823380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2003
• 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: 48 YR