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

Model Number ETPKN7SL

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Migration (4003)

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 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).

Manufacturer Narrative

Updated medical device problem code 4003.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 7 STANDARD LEF
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11412937
• MDR Text Key: 234689376
• Report Number: 3010536692-2021-00141
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN7SL1
• UDI-Public: M684ETPKN7SL1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/14/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 04/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR