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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN A/R SCREW 95MM PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. HFN A/R SCREW 95MM PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 814501095
Device Problem Fracture (1260)
Patient Problems Fall (1848); Pain (1994); Osteopenia/ Osteoporosis (2651)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03729. Concomitant medical devices: part# 814511180; lot# unk; part# 814510115; lot# vk1121315a; part# 814550040; lot# unk. Foreign - event occurred in denmark. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported approximately one (1) year and four (4) months ago, patient was implanted with an unknown affixus nail to repair a trochanter femoris fracture on the right side. Approximately seven (7) months post-op, the patient fell. Xrays were taken approximately four (4) months ago due to patient experiencing pain, and x-rays had shown the nail had fractured. Patient was revised approximately two (2) months ago to remove the nail. During the surgery, a screw was also discovered to have fractured. Attempts have been made and no further information has been provided.
 
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Brand NameHFN A/R SCREW 95MM
Type of DevicePROSTHESIS, TRAUMA
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 Key11021565
MDR Text Key221850106
Report Number0001825034-2020-04368
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K100238
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814501095
Device Lot NumberUK1111295B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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