MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EPOLY 36MM RLC LNR +5 SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problems Sticking (1597); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Tissue Damage (2104); Discomfort (2330); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Fluid Discharge (2686)

Event Date 01/27/2010

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent a right total hip arthroplasty on april 20, 2004 and reports patient allegations of pain, discomfort, soreness, dysfunction, and loss of range of motion.Legal counsel for patient further alleges patient underwent a revision on september 25, 2008 and underwent a second revision on (b)(6) 2010.A review of invoice history confirms all surgery dates and that the cup and head were removed and replaced on september 25, 2008.Invoice history also indicates the head and liner were replaced during the revision procedure on (b)(6) 2010.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the patient¿s right revision operative report from september 25, 2008 was due to alval hypersensitivity, metal-on-metal reaction and necrotic avulsion of abductor mechanism.Revision operative report noted the presence of a gray stained femoral fascia, greenish tinged inflammatory serous exudates indicating alval hypersensitivity reaction, loose abductors, necrotic inflammatory reaction, extension-type impingement, and burnishing on the head and cup.The acetabular cup and modular head replaced with a cup, polyethylene liner and modular head.Additional information received in the patient's revision operative report from (b)(6) 2010 indicates the revision procedure was due to dislocation.Revision operative report noted a detached iliotibial band and stained tissue.The liner and modular head were removed and replaced with a constrained head and liner.

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: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." this report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2013-00334 / 00335 & 2015-00528 /-00529).

• Brand Name: EPOLY 36MM RLC LNR +5 SZ23
• 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: 4513678
• MDR Text Key: 17298520
• Report Number: 0001825034-2015-00529
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070399
• 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: 02/03/2015

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: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: EP-156233
• Device Lot Number: 974140
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2007
• 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: 65 YR