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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM NCB FEMORAL PLATES

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ZIMMER GMBH NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM NCB FEMORAL PLATES Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products - therapy date: (b)(6) 2014. The manufacturer did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on left side and revised due to pain, implant fracture.
 
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Brand NameNCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM
Type of DeviceNCB FEMORAL PLATES
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8159809
MDR Text Key130190628
Report Number0009613350-2018-01232
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K042695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number02.03260.109
Device Lot Number2837247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2015
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: 12/13/2018 Patient Sequence Number: 1
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