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-213

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem Injury (2348)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 988h; triathlon ps fem component, cemented; cat# 5515-f-302; lot# gxmjd; tri ts baseplate size 2; cat# 5521-b-200; lot# bsdi.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

This pi is for right knee.It was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty.

Event Description

This pi is for right knee it was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed through clinician review of provided medical records.Method & results product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.Product history review: indicated all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.

• 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
• MDR Report Key: 8964783
• MDR Text Key: 156612641
• Report Number: 0002249697-2019-03101
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046236
• UDI-Public: 07613327046236
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 5532-G-213
• Device Lot Number: LCR815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR