MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MOD HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Delamination (2904)

Patient Problems Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Swelling (2091); Tissue Damage (2104); Disability (2371); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 10/27/2014

Event Type  Injury  

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 13 states, "problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies." 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 based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 1 of 3 mdr's filed for the same event (reference 1825034-2015-03860 / 03861 / 01445).

Event Description

Legal counsel for the patient alleges that patient underwent a left total hip arthroplasty on (b)(6) 2006.Patient's legal counsel reports patient allegations of pain, swelling, inflammation, lack of mobility, loss of range motion, dysfunction, elevated metal ion levels and damage to surrounding bone and tissue.No revision has been reported.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a revision procedure on (b)(6) 2014 due to elevated metal ion levels, pain, and leg length discrepancy.Revision operative report further noted presence of scarring, trunion changes, loose cup, delamination of the porous coating from the cup superolaterally, and abductor damage.The head and cup were explanted and replaced with a legacy zimmer cup and liner with an unknown head.

• Brand Name: M2A 38MM MOD HD -3MM 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: 5051262
• MDR Text Key: 24895668
• Report Number: 0001825034-2015-03860
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Report Date: 08/07/2015

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: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173661
• Device Lot Number: 158670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2006
• 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: 56 YR