MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD OPTION HEAD 28MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Granuloma (1876); Inflammation (1932); Pain (1994); Toxicity (2333); Joint Dislocation (2374)

Event Date 04/29/2014

Event Type  Injury  

Event Description

It was reported that patient underwent hip arthroplasty on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2014 due to dislocation.The modular head and acetabular liner were removed and replaced.A review of invoice history confirmed the surgery that was performed on (b)(6) 2014 was a revision procedure.Patient legal counsel reports patient underwent a left total hip arthroplasty (tha) on (b)(6) 2007 and a right tha on (b)(6) 2011.Legal counsel for the patient further reports patient underwent left hip revision procedure on (b)(6) 2014 and an additional left revision procedure on (b)(6) 2014 due to allegations of pain.There has been no reported revision procedure for the right hip.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a left revision procedure on (b)(6) 2014 due to a symptomatic metal-on-metal hip replacement.Operative report further noted fluid, metallosis and stained tissue during the procedure.The modular head and taper adapter were removed and replaced with an active articulation liner and modular head.Operative notes indicate that an additional revision procedure was performed on the left hip on (b)(6) 2014 due to a disassociation.During the procedure, it was noted that the polyethylene articulating liner was subluxed from the acetabulum, and the ceramic head was disassociated from the polyethylene component and there was presence of granulated and inflamed tissue.The polyethylene liner was deformed and fractured.The modular head and polyethylene liner were removed and replaced.

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 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity." examination of returned device found no evidence of product non-conformances.During the evaluation, the component showed evidence of wear.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 4 of 4 mdrs filed for the same event (reference 1825034-2014-04949 & 04950 & 08863).

Manufacturer Narrative

Ep-200152, act artic e1 hip brg 28x46mm, 229140, 650-1065 cer option type 1 tpr,226190, us257852, magnum trispike cup 52odx46id, 884740, 157446, m2a-magnum mod hd sz 46mm, 855540.Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD OPTION HEAD 28MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 4825051
• MDR Text Key: 18653709
• Report Number: 0001825034-2015-02449
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 118560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR