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

Catalog Number KTCC-NP40

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Muscular Rigidity (1968)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

Event Description

Allegedly the patient was revised due to stiffness (left).Revision njr index no: (b)(4).

Manufacturer Narrative

This report will be updated when investigation is complete.This is the same event as 3010536692-2014-01637, -01639.This event occurred in the (b)(6).

• Brand Name: ADVANCE(R) II COCR 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 ; 901867-441
• MDR Report Key: 4247929
• MDR Text Key: 12687017
• Report Number: 3010536692-2014-01638
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KTCC-NP40
• Device Lot Number: 068618886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/03/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention