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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM

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ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product. Znn, cmn lag screw, 10. 5 mm, 105 mm including set screw catalog no#: 47248404050 ; lot#: 2905527. 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head catalog no#: 47248404050 ; lot#: 63351068. 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head catalog no#: 47248404550 ; lot#: 63579469. 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. Where lot numbers were received, 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 right side and underwent revision surgery due to intertrochanteric malunion.
 
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Brand NameCMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 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 Key8159516
MDR Text Key130177339
Report Number0009613350-2018-01223
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 04/18/2019
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 Number47-2493-342-11
Device Lot Number2863669
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 Received04/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
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: 12/13/2018 Patient Sequence Number: 1
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