MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F502

Device Problem Material Discolored (1170)

Patient Problems Arthritis (1723); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Injury (2348); Reaction (2414)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding allergy/reaction involving an triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 13-sep-2018 indicated "the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The proximal and articulating surfaces of the femoral component.Discoloration was observed on the femoral component, likely due to the decontamination process." a material analysis has been performed.The report concluded: burnishing, scratching and third-body indentations were observed on the condyles of the insert.These are common damage modes of uhmwpe.Damage consistent with the explantation process and backside impression markings likely from contact against the baseplate were also observed on the insert.Damage was observed on the baseplate, likely from the explantation processes of the insert.Based on the analysis of these implants, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant revealed "on (b)(6) 2017 a primary right total knee arthroplasty with computer guided navigation was performed for a diagnosis of osteoarthritis.The operative report describes spinal anesthesia and the use of a tourniquet.An office visit of (b)(6) 2017 notes, ".Doing well.Pain control difficult.Follow-up six weeks post-op." when seen on (b)(6) 2017 for p.T.Onset the note states,".Complains of severe right knee pain.Active range of motion 22° to 98°." on (b)(6) 2017 it was noted,".Patient generally pleased with progress.Decreased pain and ambulating well.X-ray unchanged.Return three months." the patient returned on (b)(6) 2017 and it was noted, "complains of increased pain with activity.4 over 10.Range of motion 0° to 120°.Excellent stability.No limp.Intermittent rash.Rule out allergic reaction, consider revision.Return three months." when the patient returned on (b)(6) 2017 it was noted, "trouble getting metal allergy test done.Physical examination: no change, no limp.Full range of motion 0° to 120°.On (b)(6) 2017 metal ltt analysis report for a sample collected (b)(6) 2017 states, "moderate reaction to nickel and vanadium, mildly reactive to cobalt and chromium.Note patient has competitor's right total hip arthroplasty with titanium, aluminum, vanadium stem and tantalum trabecular acetabulum.".On (b)(6) 2018 a note states, "will undergo revision right tka.For severe nickel allergy.".On (b)(6) 2018 a revision right total knee arthroplasty, femur and tibia, was performed.The operative report describes spinal anesthesia and the use of a tourniquet.The report notes, "removed poly liner.Removed femur with osteotomes and reciprocating saw without significant bone loss.Osteotomes, saws and hand tools to remove tibia without significant bone loss.Cement removed.All components were competitor's products, along with two units of simplex cement with tobramycin and cement restrictors in both the tibia and femur.X-rays dated (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017 are multiple views of the right knee, essentially unchanged demonstrating no loosening, migration or pathology.X-rays dated (b)(6) 2017 are ap/lateral and patellar views of the right knee, and are unchanged.X-rays dated (b)(6) 2018 are an ap/lateral and patellar view of the right lmee demonstrating a long-stem modular ps revision total knee arthroplasty with hybrid cementing technique.A material analysis report dated september 13, 2018 of a triathlon 5/11 x3 cr insert, a #5 right cemented femoral component, and a #5 ts baseplate includes fifteen photographs of the explanted devices with close-ups of the damage to the articular surface of the poly insert.The conclusions of this report are: burnishing, scratching and third body indentations were observed on the insert which are routinely described damage modes of poly inserts; "darn.Age" consistent with explantation process was noted on the baseplate and insert; and no materials or manufacturing discrepancies were noted on the surfaces examined.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event was not confirmed by medical review.Review of the medical review revealed that "no surgical histopathology or description of intraoperative findings suggestive of metal allergy as a source of this persistent pain present since immediately post-operative and persisting in this patient with chronic pain syndrome and narcotic dependence is noted.The single metal allergy test in which no highly reactive results were noted in a patient with two previous uncemented total hip arthroplasties and an allergic history is not confirmation of metal allergy as the source of his persistent pain.Confirmed diagnosis of metal allergy as the source of post-op tka symptoms is rare.Reflex sympathetic dystrophy and the fact that 20% of all total knee arthroplasty patient's have some persistent discomfort is a more likely explanation.The material analysis report rules out prosthetic material or manufacturing factors as contributing to this clinical situation." no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported that his initial knee surgery was done on (b)(6) 2017.He has been experiencing pain and surgical issues for the past 13 months since his surgery which led to a revision on (b)(6) 2018.Patient would also like to know if there is any compensation available.Update as per medical review received stated that " on (b)(6) 2018 a note states, "will undergo revision right tka.For severe nickel allergy.".On (b)(6) 2018 a revision right total knee arthroplasty, femur and tibia, was performed.".

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7977796
• MDR Text Key: 124103002
• Report Number: 0002249697-2018-03425
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 5510F502
• Device Lot Number: B6X9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2017
• 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: 72
• Patient Weight: 83