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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL INSERT COMPONENT; ANKLE, PROSTHESIS

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ZIMMER BIOMET, INC. TIBIAL INSERT COMPONENT; ANKLE, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).Concomitant medical products: talar component, cat: 00830002200, lot: 63744029.Tibial base component, cat: 00830004200, lot: 64136441.It is unknown if product will be returning to 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 the patient was revised approximately one year post-implantation due to infection.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10 device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
No further event information available at the time of this report.
 
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Brand Name
TIBIAL INSERT COMPONENT
Type of Device
ANKLE, PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9677248
MDR Text Key177998193
Report Number0001822565-2020-00506
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model NumberN/A
Device Catalogue Number00830005200
Device Lot Number64056132
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/27/2020
Initial Date FDA Received02/06/2020
Supplement Dates Manufacturer Received04/06/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
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