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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK COLLAR ARTHRODESIS NAIL, STERILE

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ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK COLLAR ARTHRODESIS NAIL, STERILE Back to Search Results
Model Number N/A
Device Problems Off-Label Use (1494); Malposition of Device (2616)
Patient Problem Failure of Implant (1924)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned by the facility. 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 underwent a knee procedure. Subsequently, the patient spun into external rotation and was revised approximately 5 months post implantation. It was also noted- hcp used a dual compress mod a intercalary segment as a mid shaft femur intercalary. It was known to be off label. No additional information at this time.
 
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Brand NameMOD ARTHRO 0 DEG LCK COLLAR
Type of DeviceARTHRODESIS NAIL, STERILE
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 Key13515208
MDR Text Key286763581
Report Number0001825034-2021-03300
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260600
Device Lot Number913200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2020
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: 02/11/2022 Patient Sequence Number: 1
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