MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-MET POROUS FEMORAL 50% NC 12X180; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Debris, Bone Shedding (1803); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Fluid Discharge (2686)

Event Date 09/16/2004

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2004.Legal counsel further reported patient allegations of infection, loss of range of motion, pain, inflammation, swelling, damage to surrounding bone and tissue, and lack of mobility.No revision procedure has been reported.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in patient medical records indicates that a revision procedure was performed on (b)(6) 2004 due to staph infection.The operative report noted bloody fluid and necrotic tissue within the joint, hematoma, erythema and swelling.An irrigation and debridement was performed and the modular head was replaced.Another operative report dated (b)(6) 2004 notes revision due to chronic infection.Fluid and inflamed tissue was discovered within the joint, the sinus tract was excised and a trochanteric osteotomy was performed to remove femoral stem.All components were replaced with competitor cement spacer molds and competitor cables were used to repair the osteotomy.

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 this type of event can occur.Under possible adverse effects, number 1 states, "material sensitivity reactions.¿ number 2 states, "early or late postoperative, infection, and allergic reaction." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain." lastly, number 15 states, ¿elevated metal ion levels have been reported with metal on metal articulating surfaces.¿ review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2014-07788 & 2015-01056 / 2015-01057 / 2015-01058.

• Brand Name: BI-MET POROUS FEMORAL 50% NC 12X180
• 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: 4613128
• MDR Text Key: 18627360
• Report Number: 0001825034-2015-01058
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2013
• Device Model Number: N/A
• Device Catalogue Number: CP154045
• Device Lot Number: 905390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2003
• 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: 83 YR