MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5521-B-400

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

An event regarding patient factors involving triathlon base plate was reported.The event was not confirmed.Clinician review: a review of the provided medical records by a clinical consultant indicated: (b)(6) 2019 op report right tka diagnosis right knee osteoarthritis spinal anesthesia/ tourniquet.#5 ps right femur, #4 univ.Tib.Baseplate, #4/11ps insert, no patellar resurfacing, cemented.Uncomplicated surgery.Implant sheet simplex with tobramycin cement.(b)(6) 2019 8 weeks p/o rom 15-115 x-ray no complications" (b)(6) 2019 '.Few weeks ago developed rash."(b)(6) 2019 bone scan report right knee ".Septic arthritis and/or osteomyelitis cannot be excluded." (b)(6) 2019 aspirated 7 cc blood tinged fluid right knee." (b)(6) 2019 occupational medicine consultation ".By mid (b)(6).Knee pain worsening.Erythematous papules.Culture grew (b)(6).Treated with antibiotics ,,, started on prednisone.Reduced dermatitis.(b)(6) 2019 multiple patch tests ".Allergic contact dermatitis to a number of metals and metal compounds as well as methylmethacrylate.(b)(6) 2019 consider revision - but requires bone cement and difficult to eliminate titanium.Other option.Above knee amputation.Wants to try revision." (b)(6) 2020 "patient decided on transfemoral amputation rather then revision." (b)(6) 2020 op report right transfemoral amputation diagnosis: allergy to right tka gen.Anesthesia - resect femur 15 cm proximal to center of rotation of the knee." uncomplicated surgery.(b)(6) 2020 3 weeks p/o.Wound well healed.Having some skin reaction to metal on crutches and wheelchair." (b)(6) 2020 complains of neuropathic pain.No subsequent follow-up noted.No patient demographics, no imaging studies, no surgical pathology report, no allergy consultation, no examination of explanted components.Based upon the information available for review, no definitive relationship can be determined between the multiple patch allergy tests of various degrees of positivity and the subsequent a/k amputation.Insufficient data is present for a complete medical report, and there are no unique materials in the stryker tka that are not present in virtually every tka currently available." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: no patient demographics, no imaging studies, no surgical pathology report, no allergy consultation, no examination of explanted components.Based upon the information available for review, no definitive relationship can be determined between the multiple patch allergy tests of various degrees of positivity and the subsequent a/k amputation.There are no unique materials in the stryker tka that are not present in virtually every tka currently available.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This is what was provided in an email: patient states they had a knee replacement this past june and developed an allergy to the knee and it's components.Patient had to have leg amputated because of this.Update: medical records received cite a metal allergy.

• Brand Name: TRI TS BASEPLATE SIZE 4
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10216752
• MDR Text Key: 201147184
• Report Number: 0002249697-2020-01352
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026061
• UDI-Public: 07613327026061
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 5521-B-400
• Device Catalogue Number: 5521-B-400
• Device Lot Number: DYA3VB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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): Required Intervention
• Patient Age: 44 YR