MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; PROSTHESIS - KNEE

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Muylder, j.D., victor, j., cornu, o., kaminski, l., & thienpont, e.(2014).Total knee arthroplasty in patients with substantial deformities using primary knee components.Knee surgery, sports traumatology, arthroscopy, 23(12), 3653-3659.Doi:10.1007/s00167-014-3269-x.The product was not available for return.Root cause could not be determined due to insufficient information.Part and lot identification necessary for review of device history records and complaint history was not provided.Review of complaint history found multiple related complaints on pain, however, as pain is subjective to the patient and it cannot be determined that it is the cause of the implant, no further actions are necessary.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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.This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of a journal article titled, "total knee arthroplasty in patients with substantial deformities using primary knee components".One patient was identified in the article that required a blood transfusion post knee surgery on an unknown date.There has been no further information provided and the patient outcome is unknown.All other events will be reported in individual records which will be linked to this parent record.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS - KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6957578
• MDR Text Key: 89581545
• Report Number: 0001825034-2017-09082
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention