MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS7S10L

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

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

Please remove medical device problem code: 2923.

• Brand Name: EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11413282
• MDR Text Key: 234701613
• Report Number: 3010536692-2021-00142
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS7S10L1
• UDI-Public: M684EIS7S10L1
• 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

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS7S10L
• Device Catalogue Number: EIS7S10L
• Device Lot Number: 1590209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2021
• Date Manufacturer Received: 02/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR