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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP FEM PS NON POR SIZE 3 PRIMARY RIGHT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTIONMP FEM PS NON POR SIZE 3 PRIMARY RIGHT; KNEE COMPONENT Back to Search Results
Model Number EFPSN3PR
Device Problems Material Discolored (1170); Loose or Intermittent Connection (1371); Unstable (1667); Loss of Osseointegration (2408); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 01/29/2020
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, aseptic loosening, cs and ps type implants were included on both sides.Only ps was revised, patient had joint instability, the inserts had abnormal wear patterns and some discoloration.(b)(6).
 
Manufacturer Narrative
Included event problem codes.
 
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Brand Name
EVOLUTIONMP FEM PS NON POR SIZE 3 PRIMARY RIGHT
Type of Device
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9871772
MDR Text Key184654281
Report Number3010536692-2020-00258
Device Sequence Number1
Product Code HRY
UDI-Device IdentifierM684EFPSN3PR1
UDI-PublicM684EFPSN3PR1
Combination Product (y/n)N
PMA/PMN Number
K093552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 10/15/2020
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 Other
Device Model NumberEFPSN3PR
Device Catalogue NumberEFPSN3PR
Device Lot Number1601987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2020
Initial Date Manufacturer Received 03/02/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received03/02/2020
Supplement Dates FDA Received10/15/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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