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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET CRUCIATE TRAY
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ZIMMER BIOMET CRUCIATE TRAY Back to Search Results
Model Number 141233
Device Problems Mechanical Problem (1384); Material Too Rigid or Stiff (1544); Unstable (1667); Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Date 06/30/2015
Event Type  Injury  
Event Description
The reporter was calling because at her last doctor visit he said, "this implant has to come out." having chronic pain, cold sensations, hyperextension, swelling up like a big glove, can hear popping noise in knee, burning sensation.The implant gets stiff.It hyperextends so that it is very difficult to walk without a cane or walker because it just gives out making it impossible to walk a few feet next dr appt (b)(6) 2018 to discuss surgery.Cement bone simplex, lot# rjv119, model# 6191-1-001, exp date: 05/2017, stryker series a-pat, lot# 049600, model# 184766, exp date: 08/2024, biomet vanguard-cr-ilok-right, lot# 33550, model 183008, exp date: 08/2014, biomet cruciate tray, lot # j3506997, model# 141233, biomet vanguard-cr tibial bearing, lot# 243670, exp date: 06/2019, biomet lot # 808860, exp date: 10/2019, biomet cement bone simplex, lot# rcv037, model 6191-1-001, exp date: 12/2016, stryker.
 
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Brand Name
CRUCIATE TRAY
Type of Device
CRUCIATE TRAY
Manufacturer (Section D)
ZIMMER BIOMET
MDR Report Key7285473
MDR Text Key100692100
Report NumberMW5075364
Device Sequence Number2
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/20/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number141233
Device Catalogue Number141233
Device Lot NumberJ3506997
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age66 YR
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