MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS#4 9MME; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-409-E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Catalog numbers and lot codes of other devices listed in this report: 5510f502 triathlon cr fem comp #5 r-cem, ja27p.5551-g-350-e, triathlon asymmetric x3 patella, h17x.5520-b-400, triathlon prim tib baseplate - cemented, exa3ob.6191-1-001, simplex p full dose 1 pack, rka185.6191-1-001, simplex p full dose 1 pack, rga085.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

As per received patient letter, "i need your assistance concerning my knee replacement hardware.On (b)(6) 2020, i underwent a right total knee replacement with a stryker triathlon, cr size 5 femoral component, size 4 primary tibal tray, 9 mm cs x3 polyethylene liner, size 35 patella.For the past 6 months, i have had continuous pain and swelling of the knee and shin.As a result, i am confined to bed most of the day.Prior to surgery, i was very active, went to gym daily and worked in my garden.Most importantly, i have had very painful and unexplained "bleeds" down my calf.The "bleeds" fade and then return often associated with mere walking.I went for a second opinion and have also been seen by an infectious disease specialist who ruled out cellulitis.I have had several blood tests, x rays, ultrasounds and months of physical therapy with no relief and no answers.Do you have any reports of any adverse events with this type of implant? the doctors are perplexed why i have these ecchymosis of my leg with any movement and continuous swelling and pain.".

Manufacturer Narrative

Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.  clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "pi which represents a female patient, dob (b)(6) 1935 described as 65 inches tall and weighing 108 pounds.Her date of implantation is listed as (b)(6) 2020.The event description states: " patient letter: triathlon cr knee; past 6 months continuous pain and swelling.Second opinion: ruled out cellulitis, ecchymosis.Any reports of adverse events with this type of implant?".On (b)(6) 2020 triathlon implant labels: #5 right cr femur; #4 primary tibial baseplate; #4/9 x3 cs insert; 35/10 asymmetric patella; 2 units simplex p bone cement.Imaging studies: on (b)(6) 2016, (b)(6) 2019: multiple views right knee demonstrating osteoarthritis.On (b)(6) 2020, (b)(6) 2020: multiple views right knee demonstrating cemented tka, reduced, nominal.On (b)(6) 2020: doppler images right lower extremity - no gross pathology noted.Multiple radiology reports essentially confirming previous descriptions.On (b)(6) 2020: color photograph of knee and proximal tibial region, intact skin, large area of ecchymosis from area of joint line extending distally.No clinical or pmh, no operative reports, no laboratory reports, no description of knee examination or physical therapy evaluation.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.Re pi - addendum: this addendum to my previous report includes review of the following additional documentation.On (b)(6) 2020: radiology report right knee: "right knee arthroplasty.No evidence of hardware complication or malalignment.".Ultrasound right lower extremity: "no evidence for dvt".On (b)(6) 2020 discharge summary: diagnosis "right knee: hematoma." adm on (b)(6) 2020, discharged home on (b)(6) 2020.On (b)(6) 2020 infectious dis.Consult: impression "spontaneous bleed: right knee.No evidence of infection." crp less than 20.On (b)(6) 2020 x-ray report right knee: "tka anatomic alignment." on (b)(6) 2020 microbiology report: blood culture.No growth." on (b)(6) 2020 radiology report right knee: "tka anatomical position, without evidence of loosening." on (b)(6) 2020 discharge summary: admission on (b)(6) 2020, discharged on (b)(6) 2020, right tka.On (b)(6) 2020 operative report right tka: spinal anesthesia, tourniquet time 72 minutes, diagnosis right knee oa.Uncomplicated surgery.Review of this additional documentation neither confirms the event description nor is sufficient to create a medical report for this case." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.   complaint history review: there have been no other similar events for the reported lot.  conclusion: no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As per received patient letter, "i need your assistance concerning my knee replacement hardware.On (b)(6) 2020, i underwent a right total knee replacement with a stryker triathlon, cr size 5 femoral component, size 4 primary tibal tray, 9 mm cs x3 polyethylene liner, size 35 patella.For the past 6 months, i have had continuous pain and swelling of the knee and shin.As a result, i am confined to bed most of the day.Prior to surgery, i was very active, went to gym daily and worked in my garden.Most importantly, i have had very painful and unexplained "bleeds" down my calf.The "bleeds" fade and then return often associated with mere walking.I went for a second opinion and have also been seen by an infectious disease specialist who ruled out cellulitis.I have had several blood tests, x rays, ultrasounds and months of physical therapy with no relief and no answers.Do you have any reports of any adverse events with this type of implant? the doctors are perplexed why i have these ecchymosis of my leg with any movement and continuous swelling and pain.".

• Brand Name: X3 TRIATHLON INSERT CS#4 9MME
• 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: 10630690
• MDR Text Key: 210015053
• Report Number: 0002249697-2020-02045
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327337150
• UDI-Public: 07613327337150
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5531-G-409-E
• Device Catalogue Number: 5531G409E
• Device Lot Number: LJP613
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 49