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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT 10 MM, 36 CM

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ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT 10 MM, 36 CM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
Therapy date : (b)(6) 2018. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. 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 biomet¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on left side and underwent revision due to pain, implant fracture.
 
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Brand NameCMN FEMORAL NAIL, CCD 125, LEFT 10 MM, 36 CM
Type of DeviceCMN FEMORAL NAIL
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 Key8168401
MDR Text Key130465003
Report Number0009613350-2018-01242
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024299641
UDI-Public00889024299641
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K091566
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 Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-361-10
Device Lot Number2835326
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 Received07/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2015
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: 12/17/2018 Patient Sequence Number: 1
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