MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MLRY-HD POR FMRL 14X175MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Hematoma (1884); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thrombus (2101); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/23/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent right total hip arthroplasty on (b)(6) 2008.Legal counsel further reports patient underwent revision procedure on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone/tissue, lack of mobility, soreness, dysfunction, loss of range of motion, metal poisoning, metallosis, and elevated metal ion levels.Review of invoice history revealed procedures on (b)(6) 2001 and (b)(6) 2008.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 patient underwent right total hip arthroplasty on (b)(6) 2001 and revision procedures on (b)(6) 2008 and (b)(6) 2013.The revision on (b)(6) 2008 was due to dislocations.The patient¿s operative report noted clotted hematoma blood, which was dark and multiple clots were removed.The revision on (b)(6) 2013 was due to pain and leg length discrepancy.The patient¿s operative report noted the acetabular component had poor bone ingrowth, osteolysis, brown muddy substance, and cysts.All components were removed and replaced with competitor's components.

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 deviations.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." number 15 states, "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." and " undesirable shortening of limb." this report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.This report is number 7 of 7 mdrs filed for the same patient (reference 1825034-2014-06754 / 06758 and 08693 / 08694).

• Brand Name: MLRY-HD POR FMRL 14X175MM
• 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: 4264618
• MDR Text Key: 15908527
• Report Number: 0001825034-2014-08694
• 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: 11/03/2014

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: 10/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 11-104114
• Device Lot Number: 524010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2000
• 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: 43 YR