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-602

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.A supplemental report will be submitted upon completion of the investigation.

Event Description

Approximately 7 or 8 months after knee surgery (2013) the patient started experiencing pain and aches (constant pain and achey stabbing feeling).Patient had a bone scan done which revealed separation.Patient was on vicodin for pain.Right knee.On 10/27/2016: update as per medical records received indicated that the patient was revised due to loosening.

Manufacturer Narrative

An event regarding loosening involving an triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: review of medical records by a consulting clinician indicated: "on (b)(6) 2014 a revision of the right total knee arthroplasty was performed involving the femoral and tibial component and a primary resurfacing of the patella was performed for a diagnosis of aseptic loosening right total knee arthroplasty component.The operative report describes the use of a tourniquet.It further notes, ¿femoral component grossly loose and removed ¿ frozen section negative for infection ¿ tibial component some loosening on medial side with some erosion of the bone.[.] on (b)(6) 2014 an ap and lateral and patellar view of the right showed ¿increased lucency surrounding femoral component ¿ consistent with loosening ¿ tibial component appears stable.¿ [.] based upon review of the two hospital admissions there is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.X-ray printouts available for review include a series dated (b)(6) 2013 demonstrating an osteoarthritic right knee, primarily involving the medial component.X-rays dated (b)(6) 2014 are an ap, lateral and patellar view of a cemented posterior stabilized total knee arthroplasty with no patellar resurfacing noted on the lateral.And also on the lateral x-ray, radiolucency is noted around the femoral component.X-rays dated (b)(6) 2014 are an ap and lateral of the right knee demonstrating a cemented long-stem modular revision total knee arthroplasty and patellar resurfacing, all in nominal position, with a post-operative dressing applied.Review of this additional documentation does not alter the conclusions of my previous report." -device history review: not performed as a lot was not provided.-complaint history review: not performed as a lot was not provided.Conclusions: based off the medical review, femoral and tibial loosening is confirmed however, the exact cause of the event could not be determined because insufficient information was provided.Further information such as x-rays, examination of the explanted components and medical records confirming symptoms are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened and re-evaluated.A capa trend analysis was conducted for the reported failure mode and concluded that loosening may result from other factors not necessarily related to the device.

Event Description

Approximately 7 or 8 months after knee surgery (2013) the patient started experiencing pain and aches (constant pain and achey stabbing feeling).Patient had a bone scan done which revealed separation.Patient was on vicodin for pain.Right knee.On 10/27/2016: update as per medical records received indicated that the patient was revised due to loosening.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6118286
• MDR Text Key: 60571072
• Report Number: 0002249697-2016-03711
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5515-F-602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Weight: 84