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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZNN NAIL PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. UNK ZNN NAIL PROSTHESIS, TRAUMA Back to Search Results
Catalog Number UNK ZNN NAIL
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); No Information (3190)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Full establishment name - (b)(4). Foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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
It was reported during a clinical study that a patient underwent a revision surgery of a znn femur nail due to unknown reasons within the current calendar year. The exact date of the revision surgery is unknown. Attempts have been made and no further information has been provided.
 
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Brand NameUNK ZNN NAIL
Type of DevicePROSTHESIS, TRAUMA
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 Key10613736
MDR Text Key209409693
Report Number0001822565-2020-03417
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK ZNN NAIL
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 Received04/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 10/01/2020 Patient Sequence Number: 1
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