• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE E RIGHT PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE E RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Thrombosis (2100); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01627, 0002648920-2019-00291, 0001822565-2019-01628, and 0002648920-2019-00292. Concomitant medical devices: stemmed tibial component precoat size 5, catalog#: 00598004701, lot#: 62316934; articular surface size green/c-h 10 mm height, catalog#: 00595204010, lot#: 62213181; all poly patella size 38 mm dia. Standard 9. 5 mm thickness catalog#: 00597206538, lot#: 62038971; palacos r 1x40 single, catalog#: 00111214001, lot#: 74424287. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that patient underwent right total knee arthroplasty. Subsequently, patient has been experiencing pain, limited range of motion, and difficulty ambulating. Patient also reported recurrent blood clots since the primary procedure. No revision procedure has been reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMORAL COMPONENT POROUS SIZE E RIGHT
Type of DevicePROSTHESIS, 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 Key8531579
MDR Text Key142491265
Report Number0001822565-2019-01627
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00597201502
Device LOT Number62224036
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/19/2019 Patient Sequence Number: 1
-
-