MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE(R) II TIBIAL BASE; KNEE COMPONENT

Catalog Number KTCC-NP20

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient had a primary tkr using amp on xxx.Allegedly the tibial base plate subside by approx 30 degrees and allegedly a revision was performed.Alleged use of 2x 14 mm medial pivot insert during the revision.

• Brand Name: ADVANCE(R) II TIBIAL BASE
• 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: 6957903
• MDR Text Key: 89593578
• Report Number: 3010536692-2017-01333
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K960617
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KTCC-NP20
• Device Lot Number: 1700054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/10/2017
• Date Manufacturer Received: 10/10/2017
• 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
• Patient Age: 79 YR