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

Model Number 5532-G-309

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Scar Tissue (2060); Injury (2348)

Event Date 12/17/2013

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been two other events for the lot referenced.The following devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-402; lot# fmua, triathlon prim tib baseplate - cemented; cat# 5520-b-300; lot# gmab, triathlon asym patella a32x10; cat# 5551l320; lot# 5551l320.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Based on the medical review for another pi, on (b)(6) 2013 the office note states, "right knee, pain free april started hurting by june very bad nothing helped considered revision physical examination right knee full extension and flexion, no effusion, no erythema, no warmth, no instabilityglobal tenderness plan arthroscopic evaluation with lysis of adhesions/scar debridement." on (b)(6) 2013 an arthroscopic evaluation with lysis of adhesion and extensive partial synovectomy was performed for a pre- and post-operative diagnosis of "right painful total knee replacement/adhesions/scar".The operative notes states."two plica-like structures removed other scar tissue removed".

Manufacturer Narrative

An event regarding revision due to pain involving triathlon ps fem component, cemented was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: there is no examination of explanted components, no radiographs or imaging studies consistent with faulty implants, no confirmation of metal allergies related to alleged symptoms, and no surgical histopathology consistent with metalosis, altr or particle disease.The explanation for the "grayish debris" noted in the operative report of the second arthroscopic intervention, status-post the primary total knee arthroplasty, could be from the residual hematoma from the first arthroscopic intervention.No indication for the two arthroscopic interventions or the subsequent revision total arthroplasty is demonstrated other than a painful total knee arthroplasty.Fully twenty percent of all total knee arthroplasty patients have persistent post-operative pain, and in the absence demonstrated loosening, instability, stiffness or sepsis there is not usually an indication for surgical intervention, particularly in a patient requiring increased disability benefits and with pain described as "global", rather than localized.Based upon the documentation available for review, there is no indication that this clinical situation was related to factors associated with implant design, manufacturing or materials.The fact that symptoms persisted on (b)(6) 2019, one year after all the stryker components were removed, is also meaningful to consider.Product history review: a review of the device manufacturing records indicate that 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: based on medical review, there is no examination of explanted components, no radiographs or imaging studies consistent with faulty implants, no confirmation of metal allergies related to alleged symptoms, and no surgical histopathology consistent with metalosis, altr or particle disease."grayish debris" could be from hematoma from first arthroscopic intervention.No indication for the two arthroscopic interventions or the subsequent revision total arthroplasty is demonstrated other than a painful total knee arthroplasty.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, radiographs or imaging studies consistent with faulty implants, confirmation of metal allergies related to alleged symptoms, and surgical histopathology 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 to indicate further evaluation is warranted, this record will be reopened.

Event Description

Based on the medical review for another pi, on (b)(6) 2013 the office note states, ".Right knee.Pain free.April started hurting.By june very bad.Nothing helped considered revision.Physical examination.Right knee full extension and flexion, no effusion,, no erythema, no warmth, no instability.Global tenderness.Plan.Arthroscopic evaluation with lysis of adhesions/scar debridement." on (b)(6) 2013 an arthroscopic evaluation with lysis of adhesion and extensive partial synovectomy was performed for a pre- and post- operative diagnosis of "right painful total knee replacement/ adhesions/scar".[.] the operative notes states.".Two plica-like structures removed.Other scar tissue removed.".

• 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: 9520430
• MDR Text Key: 186180533
• Report Number: 0002249697-2019-04119
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050646
• UDI-Public: 07613327050646
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 5532-G-309
• Device Catalogue Number: 5532-G-309
• Device Lot Number: MKR7H4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71