MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION(TM) MP CS INSERT; KNEE COMPONENT

Catalog Number EIS3-S10L

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly, rep attended case & surgeon noted it went very well.All ligament etc were intact and everything felt good.Somewhere between recovery and the ward, with local anesthetic still in the knee, the patient tried to weight bear and the knee dislocated, as shown in the attached x-ray.It was reduced under x-ray and was still incredible stable.Unfortunately the following day, due to the initial stretching/trauma, the knee dislocated again.Surgeon revised with a new, thick 17mm poly.Knee was more stable but not perfect, despite some additional ligament balancing.Njrr report will detail: dislocation with revision of poly.

• Brand Name: EVOLUTION(TM) MP CS INSERT
• Type of Device: 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: 6191346
• MDR Text Key: 62906882
• Report Number: 3010536692-2016-01542
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2016

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 Catalogue Number: EIS3-S10L
• Device Lot Number: 1645861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/11/2016
• Initial Date Manufacturer Received: 12/11/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention