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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM; KNEE COMPONENT Back to Search Results
Model Number 25001208
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code Bone Fracture(s) (1870)
Date of Event 04/03/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient underwent a revision surgery due to the tibial hinge component post fracturing.
 
Additional Manufacturer Narrative
This product is not commercially available by mpo.Therefore the event is not reportable.Please void the initial report.
 
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Brand Name
GUARDIAN TIBIAL SLEEVE POLY SPACER 8MM
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10071575
Report Number3010536692-2020-00362
Device Sequence Number2848255
Product Code JDI
UDI-Device IdentifierM684250012081
UDI-PublicM684250012081
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K013035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/28/2020
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
Operator of Device Other
Device Model Number25001208
Device Catalogue Number25001208
Device Lot Number1699786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/01/2020
Initial Date Received by Manufacturer 05/01/2020
Supplement Date Received by Manufacturer05/01/2020
Initial Report FDA Received Date05/19/2020
Supplement Report FDA Received Date10/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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