MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC MICROP FMRL 9.0MM; PROSTHETIC, HIP

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Toxicity (2333); Hip Fracture (2349); Ambulation Difficulties (2544); Fibrosis (3167)

Event Date 03/15/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2009.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2011 due to patient allegations of pain, bone/tissue damage, loss of range of motion, elevated metal ion levels and metallosis.Review of invoice history confirms the modular head, taper adapter and femoral stem were removed and replaced.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 (b)(6) 2011 revision was due to pain with ambulation and inability to walk.Patient had also experienced a periprosthetic greater trochanteric hip fracture treated with a cable, and subsequently had loosening of the stem component.The patient¿s operative report noted fibrous tissue within the canal of the femur.

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 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." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2014-06803 / 06805).

• Brand Name: TAPERLOC MICROP FMRL 9.0MM
• Type of Device: PROSTHETIC, 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: 4240981
• MDR Text Key: 19586949
• Report Number: 0001825034-2014-08584
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050441
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 14-103203
• Device Lot Number: 029990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2009
• 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: 56 YR