MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET HIP FRACTURE FMRL 12MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent metal-on-metal hip arthroplasty on (b)(6) 2003.Subsequently, patient's legal counsel reports patient allegations of pain, lack of mobility, bone/tissue damage, loosening and metallosis.There has been no reported revision procedure to date.A review of invoice history confirmed the initial surgery date; however, invoice history revealed that a bi-polar hip was implanted during the initial procedure and not a metal-on-metal hip.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the operative report noted patient underwent a left hip bipolar hemiarthroplasty on (b)(6) 2003 and a left hip revision on (b)(6) 2006 due to pain and stem loosening.Operative report noted the presence of fluid, no metal staining and stem was easily removed.All components were removed and replaced with a competitor total hip.

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: "intraoperative or postoperative bone fracture and/or postoperative pain." and "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." 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 1825034-2014-06589 / 06590 & 2015-01213).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information in the event description.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Event Description

Legal counsel for patient reported patient underwent a hip replacement surgery on (b)(6) 2003.Subsequently, patient's legal counsel reports patient allegations of pain, lack of mobility, bone/tissue damage, loosening and metallosis.There has been no reported revision procedure 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 operative report noted patient underwent a left hip bipolar hemiarthroplasty on (b)(6) 2003 and a left hip revision on (b)(6) 2006 due to pain and stem loosening.Operative report noted the presence of fluid, no metal staining and stem was easily removed.All components were removed and replaced with a competitor total hip.

• Brand Name: BIOMET HIP FRACTURE FMRL 12MM
• 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: 4634776
• MDR Text Key: 5612198
• Report Number: 0001825034-2015-01213
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953925
• 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: 04/01/2015

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: 07/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 162902
• Device Lot Number: 772320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2003
• 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: 64 YR