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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Date 12/27/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer did receive per for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, 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. (b)(4).
 
Event Description
Patient was implanted on the unknown side and underwent revision surgery due to implant fracture.
 
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Brand NameCMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING 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 Key11162728
MDR Text Key226542101
Report Number0009613350-2021-00010
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024298934
UDI-Public00889024298934
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-212-13
Device Lot Number2869577
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 Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2016
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

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
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