MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515-F-301

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 12/09/2014

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "loose total knee replacement of left knee".

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "loose total knee replacement of left knee".

Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "on (b)(6) 2014 patient underwent a left tka.Initially did well than developed increasing pain to the point where it was interfering with basic activities of daily living.This knee was revised on (b)(6) 2014.Operative records from the revision surgery indicate that the tibial component was loose and had collapsed in to varus malposition.The femoral component was also noted to be ¿partially loose¿.Review of these records confirm revision surgery of a tke was performed for loss of component fixation.The root cause of the loosening cannot be determined as insufficient information was available.Documentation which would aid in the further completion of this assessment would include: dated pre and post op x-ray from the index and revision surgeries.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that patient was revised due to loosening of the knee.The available medical records were provided to consulting clinician for a review which concluded that review of these records confirm revision surgery of a tke was performed for loss of component fixation.The root cause of the loosening cannot be determined as insufficient information was available.No further investigation is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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: 8568437
• MDR Text Key: 143667841
• Report Number: 0002249697-2019-01780
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• 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: 07/02/2019

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: 11/30/2017
• Device Catalogue Number: 5515-F-301
• Device Lot Number: HXFHA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR