MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6R; IMPLANT

Catalog Number 5517F602

Device Problems Mechanical Problem (1384); Unstable (1667); Unintended Movement (3026)

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

Event Date 03/31/2015

Event Type  Injury  

Event Description

The patient complained of unstable knee in flexion.Knee is 6 years old and was fine until last year.Dr.(b)(6) revised the knee for instability.Dr.Used a triathlon ts femur and insert during the revision.Right knee.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding instability involving a triathlon femoral component was reported.The event was not confirmed.Method and results: device evaluation and results: some bone residue remained attached to the device and there are some scratches on the distal articulating surface but other than these, the device appears unremarkable.A material analysis was performed.The mar report concluded: the returned device was examined with the aid of a stereo microscope at magnifications up to 50x.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: indicated that there have been no other similar reported events for the lot referenced.Conclusions: the exact cause of the event could not be determined due to insufficient provision of information.Further information such as x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation to determine root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient complained of unstable knee in flexion.Knee is 6 years old and was fine until last year.Dr.(b)(6) revised the knee for instability.Dr.Used a triathlon ts femur and insert during the revision.Right knee.

• Brand Name: TRIATHLON P/A CR BEADED #6R
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4719405
• MDR Text Key: 5737766
• Report Number: 0002249697-2015-01333
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 5517F602
• Device Lot Number: SKTKJ2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2008
• 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
• Patient Age: 59 YR
• Patient Weight: 89