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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 4 STANDARD LEF; KNEE COMPONENT

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MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 4 STANDARD LEF; KNEE COMPONENT Back to Search Results
Model Number ETPKN4SL
Device Problem Loss of Osseointegration (2408)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, patient underwent l tkr on (b)(6) 2018, primary surgeon has since retired.Revised on (b)(6) 2023 due to tibial loosening.Cement and implant were solid, but patient reported pain.Revised with evolution revision tibial base and a thicker insert.
 
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Brand Name
EVOLUTION®MP TIB KEELED NONPOR SIZE 4 STANDARD LEF
Type of Device
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key16656121
MDR Text Key312431596
Report Number3010536692-2023-00036
Device Sequence Number1
Product Code HRY
UDI-Device IdentifierM684ETPKN4SL1
UDI-PublicM684ETPKN4SL1
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K093552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/10/2023
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 Other
Device Model NumberETPKN4SL
Device Catalogue NumberETPKN4SL
Device Lot Number1755895
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/31/2023
Supplement Dates Manufacturer Received03/02/2023
Supplement Dates FDA Received05/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age92 YR
Patient SexFemale
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