MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 7 STANDARD LEF; KNEE COMPONENT

Model Number	ETPKN7SL
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
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 bilateral tkr on (b)(6) 2015.Patient presented with pain in left knee, subsidence to tibia, heated bone scan.Left knee revised on (b)(6) 2021.On opening surgeon described insert as not seated properly.Femoral component easily removed by hand with cement attached, tibial component easily wedged up with osteotomy.Infection was ruled out, loosening was determined as cause.Replaced with evolution revision system with extended cementless stems.(b)(6).
Additional Manufacturer Narrative
Updated medical device problem code 4003.

• Brand Name: EVOLUTIONMP 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 Key: 11412937
• Report Number: 3010536692-2021-00141
• Device Sequence Number: 17321415
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN7SL1
• UDI-Public: M684ETPKN7SL1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Number: ETPKN7SL
• Device Catalogue Number: ETPKN7SL
• Device Lot Number: 1609891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR