MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/11/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on an unknown date.Patient's legal counsel further reported patient allegations of pain, lack of mobility, damage to bone/tissue, metallosis and elevated metal ion levels.Subsequently, patient underwent a revision procedure on an unknown date.A review of the invoice history indicates patient underwent a revision procedure on (b)(6) 2011; however, an invoice history could not be located to confirm the initial surgery date.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 6 states, ¿material sensitivity reactions.¿ number 9 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 19 states, ¿postoperative bone fracture and pain.¿ this report is number 1 of 2 mdr's filed for the same event (reference 1825034-2014-05688 and 06697).

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on an unknown date.Patient's legal counsel further reported patient allegations of pain, lack of mobility, damage to bone/tissue, metallosis and elevated metal ion levels.Subsequently, patient underwent a revision procedure on an unknown date.A review of the invoice history indicates patient underwent a revision procedure on (b)(6) 2011; however, an invoice history could not be located to confirm the initial surgery date.Additional information provided in patient medical records indicates the right total hip arthroplasty occurred in 2000.Review of invoice history confirm right total hip arthroplasty occurred on or about (b)(6) 2000.Additional information provided in patient medical records indicates the right hip revision on (b)(6) 2011 was due to pain and septic loosening.The patient's operative report noted metal stained tissue, acetabular loosening, and metallosis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: 28MM DIA COCR MOD HD -6MM NK
• 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: 3889318
• MDR Text Key: 17388296
• Report Number: 0001825034-2014-05688
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2009
• Device Model Number: N/A
• Device Catalogue Number: 163660
• Device Lot Number: 775830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/1999
• 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: 57 YR