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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG LT LG SIZE 4 PMA; PROTHESIS KNEE

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ZIMMER BIOMET, INC. OXF ANAT BRG LT LG SIZE 4 PMA; PROTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/11/2006
Event Type  Injury  
Manufacturer Narrative
Product was not returned to zimmer biomet for investigation.Without the opportunity to examine the complaint product, root cause cannot be determined.-review of device history records found these units were released to distribution with no deviations or anomalies.-review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to the time frame in which they were manufactured.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
It was reported that the patient underwent partial left knee arthroplasty on (b)(6) 2006 subsequently, on (b)(6) 2007 the patient reported occasional stiffness in left knee, manipulation under anaesthesia - left knee, right knee symptomatic - very occasional and the left knee feels tight from time to time.On (b)(6) 2010 the patient reported episodes of swelling/pain in left knee medial and laterally after long walk.On (b)(6) 2013 it was reported that the patient's left knee was warm to the touch, generalised swelling and suprapatatellar swelling in left knee and tender lateral joint line- left knee.On (b)(6) 2013 the patient reported lateral knee swelling.
 
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Brand Name
OXF ANAT BRG LT LG SIZE 4 PMA
Type of Device
PROTHESIS 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 Key6957443
MDR Text Key89572531
Report Number0001825034-2017-09085
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2011
Device Model NumberN/A
Device Catalogue Number159555
Device Lot Number1202803
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2016
Initial Date FDA Received10/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2006
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight88
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