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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL CUT BLOCK HANDLE(PK 2) INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. FEMORAL CUT BLOCK HANDLE(PK 2) INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent total knee arthroplasty. During the procedure, a femoral cut block was noted to be fractured while on the back table. No adverse events have been reported as a result of the malfunction.
 
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Brand NameFEMORAL CUT BLOCK HANDLE(PK 2)
Type of DeviceINSTRUMENT, 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 Key8917017
MDR Text Key155275712
Report Number0001825034-2019-03702
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMEPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-487110
Device Lot Number800250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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