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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 38MM +5HW LNR PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 38MM +5HW LNR PROSTHESIS, HIP Back to Search Results
Catalog Number EP-195234
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/01/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: pt-106058- regen/rnglc+ multi- 587490, 11-173663- m2a 38mm mod hd- 005910, 103533- ti low profile screw- 366080, 103538- ti low profile screw- 170890, 103535- ti low profile screw- 199290, 31-323230-rnglc+ acet drl bit- 466490, 31-323240-rnglc+ acet drl bit- 572480. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05121, 0001825034 -2019 -05124. 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 patient has been indicated for revision due to unknown reason; however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameE-POLY 38MM +5HW LNR
Type of DevicePROSTHESIS, HIP
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 Key9311954
MDR Text Key166370465
Report Number0001825034-2019-05122
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
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 Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2011
Device Catalogue NumberEP-195234
Device Lot Number933920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2008
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: 11/12/2019 Patient Sequence Number: 1
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