MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD +9MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Toxicity (2333); Disability (2371)

Event Date 08/14/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported patient underwent right total hip arthroplasty on (b)(6) 2008 and a left total hip arthroplasty on (b)(6) 2009.Legal counsel further reports patient allegations of elevated metal ion levels, pain, inflammation, dysfunction, loss of range of motion, metal poisoning and metallosis.No revision procedure has been reported to date.

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.The following sections could not be completed with the limited information provided.Expiration date - unknown, pma/510(k) number - unknown, manufacture date - unknown.

Manufacturer Narrative

There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions." and "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." and "intraoperative or postoperative bone fracture and/or postoperative pain." and "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-04119 & 2015-01609).

Event Description

Patient's legal counsel reported patient underwent right total hip arthroplasty on (b)(6) 2008 and a left total hip arthroplasty on (b)(6) 2009.Legal counsel further reports patient allegations of elevated metal ion levels, pain, inflammation, dysfunction, loss of range of motion, metal poisoning and metallosis.No revision procedure has been reported 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 right hip revision on (b)(6) 2014 due to pain, dislocation, subluxation and instability.Operative report noted the presence of a fluid collection and no metallosis.The modular head, acetabular cup and liner were removed and replaced.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined component was not explanted.

• Brand Name: 32MM M2A HI CARBON HD +9MM 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3812161
• MDR Text Key: 4402116
• Report Number: 0001825034-2014-04119
• 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,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR