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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN FEMORAL NAIL TRAUMA IMPLANT

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ZIMMER BIOMET, INC. ZNN FEMORAL NAIL TRAUMA IMPLANT Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problem Erosion (1750)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -02252, 0001822565 -2019 -02253, 0001822565 -2019 -02255. Device discarded.
 
Event Description
It was reported that the patient was transferred from another center. The znn lag screw starting to cut out of the femoral head. After examining the extent of bone loss in proximal femur, it was decided to perform a total hip arthroplasty. Nail was explanted using znn and its instruments. Surgery was completed with another cpt stem with no delay in the procedure. Attempts have been made and no further information has been provided.
 
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Brand NameZNN FEMORAL NAIL
Type of DeviceTRAUMA IMPLANT
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 Key8651272
MDR Text Key146408943
Report Number0001822565-2019-02251
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
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