MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET CC I-BEAM TRAY 71MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Reaction (2414); No Information (3190)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided.Device code - ni, expiration date - ni, initial reporter, manufacture date ¿ ni.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.Product location unknown.

Event Description

Patient underwent a knee revision procedure approximately eight months post-implantation due to loosening of the cement.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to correct information.

Event Description

Patient underwent a knee revision procedure approximately eight months post-implantation due to loosening of the cement.Patient alleges they were told the implants were not initially implanted correctly.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Event Description

It was reported the patient was revised due to cement loosening causing device malposition and allergic reaction.No further information has been made available at this time.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: d4, h2, h3, h4, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no related deviations or anomalies during manufacturing.Lab reports provided for inflammation pre-revision and anticoagulation monitoring post-revision.A definitive root cause cannot 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.

Event Description

No further information available at the time of this reporting.

• Brand Name: BIOMET CC I-BEAM TRAY 71MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5641538
• MDR Text Key: 44757734
• Report Number: 0001825034-2016-01524
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K915132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141223
• Device Lot Number: J3513122
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• 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