MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 6 STANDARD LEF; KNEE COMPONENT

Model Number	ETPKN6SL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, complete femoral and tibial bipolar loosening, major osteolysis of the femoral epiphysis and metaphysis preserving the corticals, abundant fibrinous tissue, diffuse deposits of intra-osseous and intra-articular fibrin.Less osteolysis at the tibial level.No issue with the patella.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION®MP TIB KEELED NONPOR SIZE 6 STANDARD LEF
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15158857
• Report Number: 3010536692-2022-00268
• Device Sequence Number: 20222185
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN6SL1
• UDI-Public: M684ETPKN6SL1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: ETPKN6SL
• Device Catalogue Number: ETPKN6SL
• Device Lot Number: 1623304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 85 KG