MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-METRIC/X POR COLLAR 17X165; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 04/23/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2009.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2014 due to patient allegations of pain, loss of range of motion, bone/tissue damage, elevated metal ion levels and metallosis.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¿s medical records revealed the (b)(6) 2014 revision was due to pain.The patient¿s operative report noted fluid.The head could not be disengaged from the stem; therefore, the stem had to be removed.There was a fracture line present around the greater trochanter.The head, taper adapter and stem were removed and replaced.

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 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 2 of 3 mdrs filed for the same event (reference 1825034-2014-06619 and 2015-00026).

• Brand Name: BI-METRIC/X POR COLLAR 17X165
• 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: 4384829
• MDR Text Key: 5289244
• Report Number: 0001825034-2015-00025
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK020580
• 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: 12/19/2014

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: 06/30/2012
• Device Model Number: N/A
• Device Catalogue Number: X181317
• Device Lot Number: 660240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2002
• 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: 59 YR