MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-P-411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding patient factors involving triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.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.On (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." on (b)(6) 2019 occupational medicine consultation ".By mid (b)(6).Knee pain worsening.Erythematous papules.Culture grew staph.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.On (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." on (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.On (b)(6) 2020 3 weeks p/o.Wound well healed.Having some skin reaction to metal on crutches and wheelchair." on (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 or Problem Description
This is what was provided in an email: patient 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: TRIATHLON #4 PS INSERT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10211345
• Report Number: 0002249697-2020-01340
• Device Sequence Number: 14120378
• Product Code: MBH
• UDI-Device Identifier: 07613327042726
• UDI-Public: 07613327042726
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 5532-P-411
• Device Catalogue Number: 5532P411
• Device Lot Number: LHM711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR