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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 11.5 MM, 40 CM FOD, FIXATION

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ZIMMER BIOMET, INC. CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 11.5 MM, 40 CM FOD, FIXATION Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 11/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient had an intramedullary nailing for a right sub-trochanteric femoral fracture; during the procedure the c-arm pushed against the non-operative leg, which was up in a stirrup, dislocating the left hip. The patient was reduced satisfactorily.
 
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Brand NameCMN FEMORAL NAIL, CCD 130°, RIGHT, ø 11.5 MM, 40 CM
Type of DeviceFOD, FIXATION
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 Key8453384
MDR Text Key139896389
Report Number0001822565-2019-01263
Device Sequence Number1
Product Code HSB
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number47249340211
Device Lot Number2512621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/26/2019 Patient Sequence Number: 1
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