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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product was not available for return.Without the opportunity to examine the complaint products, root cause cannot be determined.Condition is addressed through the warnings in the package insert.Part and lot identification are necessary for review of device history records and complaint histories, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert 01-50-0950 biomet hip joint replacement prostheses list under possible adverse effects: ¿early or late postoperative, infection, and allergic reaction.¿ number 14 states "postoperative bone fracture and pain." under warnings it states "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." 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

One patient was identified in the article that underwent a revision procedure post tka, due to valgus/internal rotation malalignment of a femoral component on an unknown date.There has been no further information provided and the patient outcome is unknown.

• 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: 6914517
• MDR Text Key: 88206725
• Report Number: 0001825034-2017-07900
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK KNEE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2014
• 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): Hospitalization; Required Intervention