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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

Adolph v.Lombardi, jr., md*,**,¿; thomas h.Mallory, md*,**;robert a.Fada, md*; jodi f.Hartman, ms*; susan g.Capps, phd¿; cheryl a.Kefauver, rn*;and joanne b.Adams, bfa* an algorithm for the posterior cruciate ligament in total knee arthroplasty clinical orthopaedics and related research number 392, pp.75¿87 © 2001 lippincott williams and wilkins, inc.Root cause could not be determined.Part and lot identification necessary for review of device history records and complaint history was not 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 01-50-0975, there are warnings in the package insert that state this kind of event can occur.Under "possible adverse effects," number 2 states, "early or late postoperative, infection, and allergic reaction." 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

Information was received based on review of a journal article titled, "an algorithm for the posterior cruciate ligament in total knee arthroplasty¿ which compared one-hundred seventy-one (171) maxim cr (cruciate-retaining) knees and one-hundred eighty (180) maxim ps (posterior-stabilized) knees.No statistically significant differences in outcome between the groups were observed.This complaint addresses the, one (1) revision due to arthrofibrosis was performed.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: 6918889
• MDR Text Key: 88407177
• Report Number: 0001825034-2017-08074
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: UNKNOWN KNEE
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2014
• 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