MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SELEX/MAGNUM MOD HD 40MM +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 10/06/2014

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 10 states, "wear and/or deformation of articulating surfaces." 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 1825034-2015-05151 / 05152).

Event Description

It was reported by the patient's legal counsel that patient had an initial right hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2014 due to alleged elevated metal ion levels.During the procedure, metallic colored fluid and metal debris within the acetabulum were noted.The femoral head was removed and replaced with a liner to complete the procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported by the patient's legal counsel that patient had an initial right hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2014 due to alleged elevated metal ion levels and clicking.During the procedure, metallic colored fluid, metal debris within the acetabulum, a large cyst, corrosion of the trunnion, well-fixed stem, and dark gray fibrinous material were noted.The femoral head was removed and replaced and a liner was implanted to complete the procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: SELEX/MAGNUM MOD HD 40MM +3
• 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: 5324875
• MDR Text Key: 34303964
• Report Number: 0001825034-2015-05152
• 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
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: S331140
• Device Lot Number: 306200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2005
• 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: 51 YR