MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was disposed of and not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient total knee revision due to lucency and pain.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: not performed as no medical records were 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 reported loosening could not be determined with the limited information provided.Further information such as product return, x-rays, operative notes, medical records and follow-up notes are needed to complete the investigation to determine a 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

Patient total knee revision due to lucency and pain.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6185966
• MDR Text Key: 62746665
• Report Number: 0002249697-2016-03947
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 5520B500
• Device Lot Number: SBC8B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2006
• 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: 67 YR
• Patient Weight: 77