MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 05/20/2013

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent total hip arthroplasty on (b)(6) 2009 and that a subsequent revision procedure occurred on (b)(6) 2012 due to unknown reasons.Additional information in the (b)(6) 2012, right hip revision operative report noted the revision was due to pain and further noted the presence of straw-colored cloudy fluid.The acetabular cup, modular head and taper adapter were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative report noted patient underwent an additional right hip revision on (b)(6) 2013 due to dislocation and a leg length discrepancy.Revision operative report noted the presence of metallosis and debris.The modular head and liner 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 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." 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 3 of 4 mdrs filed for the same event (reference 1825034-2012-01660 & 2014-05411 /-07474 /-07475).

• Brand Name: CER BIOLOXD OPTION HD 36MM
• 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: 4054459
• MDR Text Key: 4809873
• Report Number: 0001825034-2014-07474
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• 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: 08/06/2014

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 958410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2012
• 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: 64 YR