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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ25; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ25; PROSTHESIS, HIP Back to Search Results
Catalog Number EP-108525
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 02/20/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: pt-106062-regen/rnglc+ multi-253460, s991140-selex/magnum mod-688000, 103534-ti low profile screw-155530, 103533-ti low profile screw-155480.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05126, 0001825034 - 2019 - 05129.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.
 
Event Description
It was reported the patient underwent an initial hip arthroplasty.Subsequently, the patient underwent an acetabular revision due to unknown reasons a little over two years later.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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
No additional event information to report at this time.
 
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Brand Name
E-POLY 40MM +3 HIWALL LNR SZ25
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9321261
MDR Text Key168057633
Report Number0001825034-2019-05127
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Catalogue NumberEP-108525
Device Lot Number619190
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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