MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problems Device Slipped (1584); Insufficient Information (3190)

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

Event Date 02/07/2017

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

This was a revision of a left knee due to femoral loosening.The femoral component and tibial insert were changed to a ts component and a ps insert.

Manufacturer Narrative

An event regarding pain and loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the product was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated "there are no serial x-rays confirming a loose femoral component which required osteotomes for removal at revision surgery and no mention of broken trials in the operative report.There is no examination of the broken trials or indication if they broke when forcibly impacted into the tibial tray.There is no evidence that factors of faulty component or component trial design, manufacturing or materials were responsible for this clinical situation." -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.Conclusion : the event could not be confirmed nor the root cause determined on basis of medical review.The provided medical information was submitted to a consulting clinician who indicated "there are no serial x-rays confirming a loose femoral component which required osteotomes for removal at revision surgery and no mention of broken trials in the operative report.There is no examination of the broken trials or indication if they broke when forcibly impacted into the tibial tray.There is no evidence that factors of faulty component or component trial design, manufacturing or materials were responsible for this clinical situation." further information such as device details, return of device are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

This was a revision of a left knee due to femoral loosening.The femoral component and tibial insert were changed to a ts component and a ps insert.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6382279
• MDR Text Key: 69207534
• Report Number: 0002249697-2017-00788
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5510F501
• Device Lot Number: EBDRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2012
• 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: 54 YR
• Patient Weight: 104