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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW SCREW, FIXATION

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ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW SCREW, FIXATION Back to Search Results
Model Number 47-2484-050-60
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). 5. 0 mm diameter cortical screw cat: 47248404050 lot: 64677063. 5. 0 mm diameter cortical screw cat: 47248404550 lot: 64581106. Greater trochanter femoral nail cat: 47249232011 lot: 62451700. Foreign: (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that approximately 8 months post implantation, the patient experienced a fracture and the implanted nail had also fractured and become loose. The patient was revised. No further information has been provided.
 
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Brand Name6.0 MM DIAMETER CANCELLOUS SCREW
Type of DeviceSCREW, 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 Key11313426
MDR Text Key232452852
Report Number0001822565-2021-00371
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2484-050-60
Device Catalogue Number47248405060
Device Lot Number64466394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2019
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: 02/11/2021 Patient Sequence Number: 1
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