MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 36MM +3 HIWALL LNR SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Toxicity (2333); Joint Swelling (2356)

Event Date 12/19/2009

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: "patient selection factors to be considered include: ability and willingness of the patient to follow instructions, including control of weight and activity level." this report is number 3 of 6 mdrs filed for the same patient (reference 1825034-2013-01968 / 01969 and 2014-00889 / 00892).

Event Description

Legal counsel for the patient reported that patient underwent right total hip arthroplasty on (b)(6) 2007.Patient's legal counsel further reported that a revision procedure occurred on (b)(6) 2009 due to patient allegations of pain, dysfunction, loss of range of motion, and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information provided in revision operative notes indicates the revision procedure that took place on (b)(6) 2009 was due to acetabular cup loosening and the presence of dark-colored synovial tissue consistent with metal wear.The acetabular cup and modular head was removed and replaced.Furthermore, revision operative notes indicate that three subsequent revision procedures occurred due to instability.A revision procedure took place on (b)(6) 2009 to remove and replace the acetabular liner.A revision procedure took place on (b)(6) 2010 to remove and replace the acetabular liner with a constrained liner.A revision procedure took place on (b)(6) 2010 to remove and replace the constrained liner with a tri-polar system.In addition, revision operative notes provided indicate that a revision procedure was performed on (b)(6) 2011 to remove and replace the acetabular liner.Operative notes for this revision procedure further indicate that a synovectomy was performed and that the surgeon noted polyethylene wear of the acetabular liner from anterior subluxation.

• Brand Name: E-POLY 36MM +3 HIWALL LNR 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3640462
• MDR Text Key: 19457391
• Report Number: 0001825034-2014-00889
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2012
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 158400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2009
• 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