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

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Tinnitus (2103); Weakness (2145); Sleep Dysfunction (2517)

Event Date 07/12/2018

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.Device not returned.

Event Description

It was reported through a medwatch (mw5091081) "[.] i had a left tka; by [.] 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 [.] 2019 i was evaluated and had a comprehensive workup at (b)(6) clinic in [.] 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, (b)(6), lyme's, autoimmune (b)(6) nor other viruses, syndromes, illnesses.By [.] 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.In 2019 i had metal-ltt testing and was told i had a highly reactive nickel and mildly reactive vanadium allergies.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 what is considered "anecdotal" systemic reactions to metals found in implants; i was not made aware that testing pre-operatively was available to me.[.] 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 know that this had occurred.".

• Brand Name: UNKNOWN TRIATHLON KNEE
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9560572
• MDR Text Key: 185698469
• Report Number: 0002249697-2020-00044
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• 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): Other