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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 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR PROSTHESIS, HIP Back to Search Results
Catalog Number EP-108525
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 010001032- cocr fem hd- 3147102, 21-109268- ha par-5 acet shl- 779130, x12-171313- integral/x por red- 299620, 31-109200- par-5 flange prov sz short lt- 307940, 109206- par-5 flange sz short neutral- 299720, 31-323230-rnglc+ acet drl bit- 784290, 103532- ti low profile screw- 678040, 31-323220-rnglc+ acet drl bit- 031580, 103531- ti low profile screw- 558060, 103531- ti low profile screw- 633300. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05113, 0001825034 - 2019 - 05114, 0001825034 - 2019 - 05115. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Remains implanted.
 
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.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
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Brand NameE-POLY 40MM +3 HIWALL LNR
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9311963
MDR Text Key166197258
Report Number0001825034-2019-05112
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 03/02/2020
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 Date05/30/2019
Device Catalogue NumberEP-108525
Device Lot Number181790
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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