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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT TRAUMA IMPLANT

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ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT TRAUMA IMPLANT Back to Search Results
Model Number 47-2492-321-10
Device Problem Fracture (1260)
Patient Problems Fall (1848); Pain (1994)
Event Date 02/27/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign- (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that initial surgery was performed with gtf nail on left side. Subsequently, the patient was revised due to pain from fall and fracture of the implant. Attempts have been made and no further information has been provided.
 
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Brand NameGREATER TROCHANTER FEMORAL NAIL - GREEN LEFT
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 Key9902681
MDR Text Key191898083
Report Number0001822565-2020-01074
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083497
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 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2492-321-10
Device Catalogue Number47249232110
Device Lot Number63395571
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 Received08/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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