MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CERAMIC BIOLOXD OPTION HEAD 36MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Hematoma (1884); Scar Tissue (2060); No Code Available (3191)

Event Date 06/20/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2005.Subsequently, revision procedures were performed on the right hip on (b)(6) 2014 due to metal related allegations and on (b)(6) 2014 for unknown reasons.It was further reported that a revision was performed on (b)(6) 2014 due to dislocation and acetabular protrusio.During the procedure, competitor components were implanted in the patient; it is unknown which components were explanted during the procedure.

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 or deviation.There are warnings in the package insert that state that these types of events can occur: possible adverse effects states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity." this report is number 6 of 6 mdrs filed for the same event (reference 1825034-2014-07370 / 07375).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2005.Subsequently, revision procedures were performed on the right hip on (b)(6) 2014 due to metal related allegations and on (b)(6) 2014 for unknown reasons.It was further reported that a revision was performed on (b)(6) 2014 due to dislocation and acetabular protrusion.During the procedure, competitor components were implanted in the patient; it is unknown which components were explanted during the procedure.Additional information received from patient's legal counseld reported patient was revised on the right hip on (b)(6) 2014 due to metallosis and elevated metal ion levels.The patient's right hip was further revised on (b)(6) 2014 due to "complications." subsequently, the right hip was revised on (b)(6)2014.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.Product location unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).This report is number 4 of 13 mdrs filed for the same patient (reference 1825034-2014-07370, 07371, 07372, 07373, 07375 and 2016-02250, 02251, 02253, 02255, 02256, 02257, 02260, 02261.

Event Description

Patient's legal counsel reported that patient underwent a right hip revision procedure four (4) days post-implantation due to unknown reasons.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received confirms patient was revised approximately four (4) days post-implantation due to protrusio and instability of the acetabular component.During the procedure, a hematoma and scar tissue were noted as well as a deficiency in the medial and anterior inferior walls of the acetabulum.Alllograft and bone grafts were utilized for stability and the modular head, acetabular cups and liner were removed and replaced.

• Brand Name: CERAMIC BIOLOXD OPTION HEAD 36MM
• 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: 4045340
• MDR Text Key: 4723590
• Report Number: 0001825034-2014-07373
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2016

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: 04/24/2024
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 011930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 02/11/2016; 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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: 60 YR