MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI LFIT MEDIAL FEMORAL COMP.; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 4010-007L-I

Device Problems Material Discolored (1170); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/18/2014

Event Type  Injury  

Event Description

The femoral and tibial components were revised due to loosening.At the revision surgery, the orange stains were found on the insert.The surgeon would like to know the elements of the orange stains.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown femoral component.When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding loosening involving a uni femoral component was reported.The reported revision surgery was confirmed.However, the reported loosening could not be confirmed.Method and results: device evaluation and results: no material or manufacturing defects were identified.Medical records received and evaluation: all medical records were reviewed by a consulting clinician who indicated there is no evidence that factors of faulty manufacturing or materials were responsible for this clinical situation.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the articulating surface of the tibial bearing insert contained material damage in the form of burnishing, third-body indentation, and abrasion.Eds analysis on the reported orange stain of the articulating surface indicated constitutive elements likely to have been derived from biological fluid.The exact cause of the event could not be determined because no medical records were provided for review.Additional information such as clinical/past medical history, operative reports, revision date and serial x-rays would be required for further review.No further investigation is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

The femoral and tibial components were revised due to loosening.At the revision surgery, the orange stains were found on the insert.The surgeon would like to know the elements of the orange stains.

• Brand Name: UNI LFIT MEDIAL FEMORAL COMP.
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4123316
• MDR Text Key: 19085805
• Report Number: 0002249697-2014-03645
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2006
• Device Catalogue Number: 4010-007L-I
• Device Lot Number: K01N604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention