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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD LEF; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD LEF; KNEE COMPONENT Back to Search Results
Model Number ETPKN7SL
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Unspecified Infection (1930); Inflammation (1932)
Date of Event 10/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly , the patient underwent bilateral total knee replacement on (b)(6) 2014 at (b)(6).On (b)(6) 2014, the patients c-reactive protein (cpr) level was recorded as high as 234mg/l.On (b)(6) 2018, the patients cpr level was recorded as 284mg/l.Surgeon advised that the patient would require 2 surgeries, or life-long antibiotics in order to treat the condition.(b)(6).
 
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Brand Name
EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD LEF
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9406038
Report Number3010536692-2019-01161
Device Sequence Number2166877
Product Code HRY
UDI-Device IdentifierM684ETPKN7SL1
UDI-PublicM684ETPKN7SL1
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/03/2019
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 Health Professional
Device Model NumberETPKN7SL
Device Catalogue NumberETPKN7SL
Device Lot Number1517768
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2019
Initial Report FDA Received Date12/03/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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