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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG; KNEE COMPONENT Back to Search Results
Model Number KPONTP35
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
Revision insert change left tkr-poly exchange.Patient loose in extension-lateral compartment patella lift off-patella implant removed-fracture observed post removal.12mm left cs insert removed, 35mm patella removed.14mm left cs implanted.No patella replaced and no fixation of patella knee stable in flexion and extension.
 
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Brand Name
ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9157426
Report Number3010536692-2019-01080
Device Sequence Number11224736
Product Code JWH
UDI-Device IdentifierM684KPONTP351
UDI-PublicM684KPONTP351
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K953439
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/04/2019
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 NumberKPONTP35
Device Catalogue NumberKPONTP35
Device Lot Number1708348
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/05/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/04/2019
Initial Report FDA Received Date10/04/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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