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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical product: partial articular surface; p/n: 42518200911, l/n: 63442413; partial femur cemented; p/n: 42558000601, l/n: 63532898; partial tibial cemented; p/n: 42538000901, l/n: 63556352.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01155, 0001822565 - 2019 - 01157.Remains implanted.
 
Event Description
It was reported patient has continued severe pain due to onset of bloody effusions approximately one year post implantation.No additional patient consequences were reported.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2019-03953.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2019-03953.
 
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Brand Name
PARTIAL FEMUR CEMENTED
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8470979
MDR Text Key140537706
Report Number0001822565-2019-01156
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42558000601
Device Lot Number63532898
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight81
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