MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-METRIC/X POR NC 9X125; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Fluid Discharge (2686)

Event Date 03/22/2010

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent total hip arthroplasty on (b)(6) 2005.Subsequently, legal counsel for patient reports patient was revised (b)(6) 2012 due to patient allegations of elevated cocr levels and tissue/bone destruction.No further information has been provided 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 patient's revision operative report noted the date of the revision to be (b)(6) 2010.The reason for the revision was leg length discrepancy, pain, pseudotumor, and metal hypersensitivity.Operative report further noted creamy gray fluid with a pasty consistency.The acetabular liner, modular head and femoral stem were removed and replaced with a biomet acetabular liner and competitor femoral components.Additionally, patient medical records indicate that a revision procedure was performed on an unknown date due to pseudotumor and infection.All components were removed and replaced with competitor cement spacers.

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 deviation.There are warnings in the package insert that state that this type of event can occur: "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 3 mdrs filed for the same event (reference 1825034-2012-01781 / 01782 / 1825034-2015-01986).

Event Description

Patient's legal counsel reported that patient underwent total hip arthroplasty on (b)(6) 2005.Subsequently, legal counsel for patient reports patient was revised (b)(6) 2012 due to patient allegations of elevated cocr levels and tissue/bone destruction.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 revision operative report noted the date of the revision to be (b)(6) 2010.The reason for the revision was leg length discrepancy, pain, pseudotumor, and metal hypersensitivity.Operative report further noted creamy gray fluid with a pasty consistency.The modular head and femoral stem were removed and replaced with a competitor stem and biomet ceramic head.A biomet acetabular liner was also cemented into the well-fixed cup during the revision procedure.Additionally, patient medical records indicate that a revision procedure was performed on an unknown date due to pseudotumor and infection.All components were removed and replaced with competitor cement spacers.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

• Brand Name: BI-METRIC/X POR NC 9X125
• 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: 4776243
• MDR Text Key: 16559536
• Report Number: 0001825034-2015-01986
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 10/31/2014
• Device Model Number: N/A
• Device Catalogue Number: X180309
• Device Lot Number: 293940
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2004
• 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: 34 YR