MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. STRYKER TRIATHLON KNEE IMPLANT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Tinnitus (2103); Weakness (2145); Convulsion, Clonic (2222); Arthralgia (2355); Disability (2371); Shaking/Tremors (2515); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 07/12/2018

Event Type  Injury  

Event Description

(b)(6).(b)(6) 2018 i had a l tka; by (b)(6) 2018 i developed overwhelming fatigue, weakness, pain in my joints and muscles, tinnitus, tremors, sleeplessness, brain fog, headaches and nausea and was worked up by my local hematologist for any relationship to my hemochromatosis (hh).In (b)(6) 2019 i was evaluated and had a comprehensive workup at mayo clinic in (b)(6) for thoughts this might be hemochromatosis arthropathy; i consulted with rheumatology, hepatology, psychiatry, urology, pharm d for polypharmacy, nutritionists.After a plethora of advanced imaging, labs, and urines the outcome of these consults determined my hh was not responsible for any of my complaints, i did not have arthropathy nor rheumatoid arthritis, ebw, cmv.Lyme¿s, autoimmune hepatitis nor other viruses, syndromes, illnesses.By (b)(6) 2019 i had an inability to follow conversations, find words that were familiar to me, i couldn¿t effectively critically think, i had myoclonic jerking, i no stamina to work inside an office and moved my office to home, and i went on intermittent fmla.By (b)(6) 2019 i had metal-ltt testing and was told i had a highly reactive nickel and mildly reactive vanadium allergies.I was on full fmla and short term disability.I was not asked prior to surgery if i had an allergy or sensitively to any metals in the past; i was not made aware of the possibility of allergy to implant; i was not made aware of what is considered ¿anecdotal¿ systemic reactions to metals found in implants; i was not made aware that testing pre-operatively was available to me.Had i known any possibility existed to a reaction to any of the metals would have opted to be tested for such.If it is known by the implant manufacturer and the fda, and even the surgeon that a possibility exists of a topical or systemic response to metal implants why in the world would it not be part of the pre-operative workup for a patient to receive metal ltt or melisa testing? to not disclose this information is hiding from me the possibility that i could have a reaction, it is negligent upon the metal implant manufacturers, the physicians and the fda! the undue pain and suffering i am undergoing is unbelievable! it is staggering that not one of the regulating bodies requires pre-op testing when it is known that this has occured.Period.You all are guilty of the offense of putting money before patient safety health.Fda safety report id # (b)(4).

• Brand Name: STRYKER TRIATHLON KNEE IMPLANT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 9322080
• MDR Text Key: 166752084
• Report Number: MW5091081
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/12/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 98