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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 13MM X 460MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. HFN RH 125 DEG 13MM X 460MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 814313460
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034 - 2019 - 02758, 0001825034 - 2019 - 02757, 0001825034 - 2019 - 02759. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified. No patient or surgical involvement. No further information available at this time.
 
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Brand NameHFN RH 125 DEG 13MM X 460MM
Type of DevicePROSTHESIS, KNEE
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 Key8734213
MDR Text Key149189386
Report Number0001825034-2019-02759
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814313460
Device Lot Number579360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2016
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

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