MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet tibial locking bar; p/n: 141205, l/n: unk.Report source- foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure due to pain secondary to the locking bar disassociating from the tibial tray approximately one year post implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned locking bar showed excessive wear with deep nicks.A small piece of the locking bar was fractured but was not returned.Dimensional analysis shows the locking bar is out of specifications.The bar material was verified.The sem report for fractured locking bar states that the fracture surface appeared heavily smeared with suspected biological debris attached to it.No fracture artifacts identified on the fracture that would dictate the mode of the fracture.Analysis of the locking bar determined that the locking bar contact mark & deformation observations are consistent with the bar not being fully engaged with the tibial tray.However, it cannot be confirmed with certainty whether the reported locking bar dissociation occurred due to improper insertion.Also the mode of fracture could not be determined.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 event information available at the time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8452836
• MDR Text Key: 139881144
• Report Number: 0001825034-2019-01063
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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: 141232
• Device Lot Number: J6231068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• 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