MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-309

Device Problems Peeled/Delaminated (1454); Unstable (1667); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was 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

Surgeon revised patient with mid range instability and sheered off patella.Left knee.

Manufacturer Narrative

An event regarding revision due to instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no devices were returned.-medical records received and evaluation: a review of the follow up notes does not confirm the event of instability.The provided information was reviewed by a consulting clinician and there is no evidence for the causation of instability, further documentation such as operative reports and x-rays would be required to confirm a root cause.-device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: revision surgery took place due to mid range instability.The exact cause of the instability could not be determined due to insufficient provision of information.Further information such as: return of reported devices; x-rays, operative reports, and implant retrieval are needed to complete the investigation to determine the root cause of the instability.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

Surgeon revised patient with mid range instability and sheered off patella.Left knee.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5197289
• MDR Text Key: 30238491
• Report Number: 0002249697-2015-03592
• 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: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 5532-G-309
• Device Lot Number: 8YKMHD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2007
• 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 Weight: 80