MAUDE Adverse Event Report: ZIMMER CAS ZIMMER PSI KNEE SYSTEM; TOTAL KNEE REPLACEMENT INSTRUMENTS

Model Number 20-8070-002-01

Device Problems Unstable (1667); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/05/2014

Event Type  Injury  

Event Description

A surgeon reported that upon review of his patient's x-rays afer a reported fall 6 weeks after the patient's tkr surgery that the tibial component appeared to have a excessive anterior slope.He decided to revise the patient's knee to correct the slope of the tibial component.The surgeon reported that the slope of the tibial cut was 10 degrees anterior as compared to a posterior slope f 5 degrees as was planned and instrumented for in the original tkr surgery.He had utilized psi guides as part of the instrumentation in the original tkr surgery to assist in the placement of the tkr component.

Manufacturer Narrative

The x-rays were provided from which the tibial slope was estimated at 4 degrees anterior as compared to the planned posterior slope of 5 degrees.Nevertheless per the available information no given cause could be established.Per the manufacturing records, the guides were designed and fabricated per specifications and the surgeon's approval.The patient's mri scans and the segmentation steps were also reviewed without presenting any source for the given discrepancy.It is possible that the tibial psi guide was misplaced on the patient, on that the cutting block used subsequently to guide the cut got inadvertently displaced or was inadequately fixed to the tibia.A possible factor was that the surgeon did not utilize the optional bone model of the patient which offers a method to verify the placement of the psi guide intra-operatively per the surgical plan.

• Brand Name: ZIMMER PSI KNEE SYSTEM
• Type of Device: TOTAL KNEE REPLACEMENT INSTRUMENTS
• Manufacturer (Section D): ZIMMER CAS; montreal, quebec ; CA
• Manufacturer Contact: christopher mclean ; 75 queen st.; suite 3300; montreal, quebec H3C 2-N6 ; CA H3C 2N6 ; 8614074
• MDR Report Key: 4383724
• MDR Text Key: 21841067
• Report Number: 9617840-2015-00001
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2015
• Device Model Number: 20-8070-002-01
• Device Catalogue Number: 20-8070-002-01
• Device Lot Number: 62843627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR