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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR ARTHRODESIS NAIL DIAPHYSEAL CONNECTOR INTRAMEDULLARY FIXATION ROD

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ZIMMER BIOMET, INC. MODULAR ARTHRODESIS NAIL DIAPHYSEAL CONNECTOR INTRAMEDULLARY FIXATION ROD Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned because it was not returned by hospital. Once the investigation  has been completed, a follow-up mdr will be submitted. Not returned by hospital.
 
Event Description
It was reported that the patient underwent an initial right knee arthroplasty on an unknown date. Subsequently, the patient was revised approximately one year post-implantation due to implant fracture.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Udi #: (b)(4). Reported event was confirmed by review of x-rays provided. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. X-ray review indicates that the hinged prosthesis is fractured just distal to the normal knee joint. 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.
 
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Brand NameMODULAR ARTHRODESIS NAIL DIAPHYSEAL CONNECTOR
Type of DeviceINTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8697683
MDR Text Key148001389
Report Number0001825034-2019-02527
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260605
Device Lot Number403710
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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