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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414); Fibrosis (3167)

Event Date 07/07/2015

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 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain.".

Event Description

Legal counsel for patient reported that patient underwent a hip revision procedure approximately five years post-implantation due to alleged pain.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.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, "fretting and crevice corrosion may occur at interfaces between components." number 13 states, " problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy." number 15 states, "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-01532 / 03221).

Event Description

Legal counsel for patient reported that patient underwent a hip revision procedure approximately five years post-implantation due to alleged pain.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was reported in operative report received that patient underwent a hip revision procedure approximately 5 years post-implantation due to leg length discrepancy, metallosis and elevated metal ion levels.During the procedure, corrosion of the trunnion, fibrosis, straw-colored synovial fluid, a cloudy gray substance, a cyst and retroversion of the acetabular cup were noted.The femoral head and acetabular cup were removed and replaced.An acetabular liner was also implanted.

• 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: 5643566
• MDR Text Key: 44834437
• Report Number: 0001825034-2016-01532
• 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: 07/25/2016

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: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: S031140
• Device Lot Number: 641420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2007
• 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: 61 YR