MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T UNIV 2-HOLE SHL SZ 41/52; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/21/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2002.Legal counsel reports patient allegations of pain, impairment, lack of mobility, inflammation, loss off range of motion, damage to surrounding bone and tissue and metallosis.Subsequently, patient was revised on (b)(6) 2012.Additional information provided in patient medical records indicates the left hip revision on (b)(6) 2012, was due to pain, instability, and dislocation.The patient¿s operative report noted cystic defect, synovial reaction, fibrous tissue, osteolytic lesions; and the acetabular component showed retroversion.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: 1.Material sensitivity reactions.4.Loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.6.Inadequate range of motion due to improper selection or positioning of components.8.Dislocation and subluxation due to inadequate fixation and improper positioning.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-04238 and 06393).

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/52
• 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: 3955128
• MDR Text Key: 4627414
• Report Number: 0001825034-2014-06393
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• 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: 07/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-103682
• Device Lot Number: 121140
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2002
• 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: 63 YR