MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M/H RADIAL 3-HOLE SHELL 54MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Break (1069); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Fluid Discharge (2686); Test Result (2695)

Event Date 03/18/2004

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2001 and left hip revision procedures on (b)(6) 2004 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, elevated metal ion levels, metal poisoning and metallosis.A review of invoice history revealed patient underwent a right hip arthroplasty on (b)(6) 2005.There has been no reported right hip revision procedure to date.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the operative report noted patient underwent a left hip revision on (b)(6) 2004 due to protrusio of the cup with osteolysis and screw breakage.Operative report further noted the presence of metallosis, fluid, loose acetabular cup, 2 broken screws, 1 remaining screw was ground off, defect on the acetabulum rim, and no signs of infection.The modular head, acetabular cup and liner were removed and replaced.Operative report further noted patient underwent a second left hip revision on (b)(6) 2004 due to dislocation.Operative report further noted the presence of hypertrophic synovium and membranous tissue.The acetabular cup was well fixed.The modular head and liner were removed and replaced.Operative report further noted the patient underwent a right hip arthroplasty on (b)(6) 2005.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 6 of 7 mdrs filed for the same event (reference 1825034-2014-05344 / 05348 & 2015-01118 /-01119).

• Brand Name: M/H RADIAL 3-HOLE SHELL 54MM
• 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: 4621615
• MDR Text Key: 5574142
• Report Number: 0001825034-2015-01118
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK861114
• 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: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 12-104154
• Device Lot Number: 680480
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2001
• 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: 55 YR