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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X75MM SCR ROD,FIXATION/TRAUMA

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ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X75MM SCR ROD,FIXATION/TRAUMA Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Ambulation Difficulties (2544)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent an initial right ankle arthroplasty. Approximately five (5) months after initial surgery the patient underwent a revision surgery due to a non-healing wound and the product was removed.
 
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Brand NameTI-DBLE LEAD CORT 5.0X75MM SCR
Type of DeviceROD,FIXATION/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
.
warsaw, IN 46582
5745273773
MDR Report Key11877169
MDR Text Key252434872
Report Number0001825034-2021-01585
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN NAIL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? No
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: 05/25/2021 Patient Sequence Number: 1
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