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

Model Number N/A

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 08/26/2015

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 the lot released with no recorded anomaly.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and allergic reaction." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same event/patient (reference 1825034-2016-03573 / 03587).

Event Description

Legal counsel for patient reported that patient underwent a left hip revision procedure approximately seven years post-implantation claiming the revising surgeon noted metal debris and metallosis during the procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Patient operative reports indicate chronic periprosthetic infection as well as reaction to metal on metal prosthesis as reason for revision.Pain and an acetabular defect were noted.The patient underwent and irrigation and debridement procedure and the components were replaced with antibiotic cement spacers for the first of a two stage revision procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information and corrected information.Concomitant medical products - biomet taperloc femoral stem catalog#: 103200 lot#: 884400.

Event Description

Legal counsel for patient reported that patient underwent a left hip revision procedure approximately seven years post-implantation claiming the revising surgeon noted metal debris and metallosis during the procedure.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Patient operative reports indicate chronic periprosthetic infection as well as reaction to metal on metal prosthesis as reason for revision.Pain and an acetabular defect were noted.The patient underwent and irrigation and debridement procedure and the components were replaced with antibiotic cement spacers for the first of a two stage revision procedure.The patient underwent a previous procedure to washout the joint.

• Brand Name: SELEX/MAGNUM MODULAR HEAD 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: 5941169
• MDR Text Key: 54394565
• Report Number: 0001825034-2016-03587
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: S031140
• Device Lot Number: 198720
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2007
• 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: 52 YR