MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 12MM PRESS FIT FLUTED STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6495-5-012

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Information (3190)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Rep reported revision of left knee femoral component loosening.Surgeon believed original flute stem was undersized.

Manufacturer Narrative

An event regarding femoral stem loosening involving a gmrs stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: there were no relevant reported discrepancies for the referenced lot.-complaint history review: there were no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because device return, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Rep reported revision of left knee femoral component loosening.Surgeon believed original flute stem was undersized.

• Brand Name: 12MM PRESS FIT FLUTED STEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6254355
• MDR Text Key: 64905453
• Report Number: 0002249697-2017-00224
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 6495-5-012
• Device Lot Number: 94914A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR