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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM NAIL RETRO 10.5MM X 420MM ROD, FIXATION

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ZIMMER BIOMET, INC. FEM NAIL RETRO 10.5MM X 420MM ROD, FIXATION Back to Search Results
Catalog Number 14-444242
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unequal Limb Length (4534)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign: (b)(6). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that the patient underwent a revision procedure due to leg length discrepancy. It is unknown if the procedure was related to the implant.
 
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Brand NameFEM NAIL RETRO 10.5MM X 420MM
Type of DeviceROD, FIXATION
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 Key11752575
MDR Text Key248400610
Report Number0001825034-2021-01326
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14-444242
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 Received06/02/2021
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 Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/30/2021 Patient Sequence Number: 1
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