MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR LAT FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)

Event Date 09/24/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2006 and left total hip arthroplasty on (b)(6) 20016.Patient's legal counsel further reported that a left hip revision procedure took place on (b)(6) 2010 and a right hip revision procedure took place on (b)(6) 2012, due to patient allegations of pain, inflammation, damage to surrounding bone and tissue, lack of mobility, dysfunction, soreness, metal poisoning and metallosis.Additional information provided in a review of invoice history confirmed the initial surgery dates for both hips; however, revision invoices could not be located and it is not known what was removed and replaced during the revision surgeries.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

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: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ 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.¿ number 15 states, ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ this report is number 7 of 7 mdrs filed for the same patient (reference 1825034-2014-01768 / 01774).

Manufacturer Narrative

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

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2006 and left total hip arthroplasty on "(b)(6) 2016." patient's legal counsel further reported that a left hip revision procedure took place on (b)(6) 2010 and a right hip revision procedure took place on (b)(6) 2012 due to patient allegations of pain, inflammation, damage to surrounding bone and tissue, lack of mobility, dysfunction, soreness, metal poisoning and metallosis.Additional information provided in a review of invoice history confirmed the initial surgery dates for both hips; however, revision invoices could not be located and it is not known what was removed and replaced during the revision surgeries.Additional information provided in patient medical records indicate that left hip revision procedure performed on (b)(6) 2010 was due to pain, infection, osteomyelitis and loosened prosthesis.The patient's operative report indicates placement of an antibiotic spacer during the (b)(6) 2010 revision and removal of the spacer performed on (b)(6) 2010.The patient's operative report noted inflammation.Additional information provided in patient medical records indicate that right hip revision procedure performed on (b)(6) 2012 was due to aseptic loosening, migrated acetabular component, metallosis, synovitis and capsulitis.The patient's operative report noted cloudy metallosis fluid, synovitis and thickening capsulitis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: TAPERLOC POR LAT FMRL 9X137
• 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: 3688934
• MDR Text Key: 4304123
• Report Number: 0001825034-2014-01774
• 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,Followup
• Report Date: 05/21/2014

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: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-103203
• Device Lot Number: 483060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 03/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2004
• 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: 64 YR