MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Chemical Exposure (2570); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 09/09/2007

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a total left hip arthroplasty on (b)(6) 2007.Legal counsel further reports patient was revised (b)(6) 2007 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, discomfort, dysfunction, soreness, loss of range of motion, bodily impairment, and elevated metal ion levels.A review of invoice history confirmed the above referenced dates and that the cup, modular head, and liner were removed and replaced.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 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 1825034-2014-05777 / -05778).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions.".

Event Description

Legal counsel for patient reported patient underwent a total left hip arthroplasty on (b)(6) 2007.Legal counsel further reports patient was revised (b)(6) 2007 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, discomfort, dysfunction, soreness, loss of range of motion, bodily impairment, and elevated metal ion levels.A review of invoice history confirmed the above referenced dates and that the cup, modular head, and liner were removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a left hip revision on (b)(6) 2007 due to pain, impingement and subluxation.Revision operative report noted the presence of a thickened capsule.The acetabular cup, taper liner and modular head were removed and replaced.

• Brand Name: 32MM M2A HI CARBON 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: 3901711
• MDR Text Key: 4653223
• Report Number: 0001825034-2014-05778
• 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,Followup
• Report Date: 07/11/2014

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: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-163687
• Device Lot Number: 006330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 06/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2006
• 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: 36 YR