MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #5 CS ALLPOLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5534-A-509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: this patient was part of the triathlon all-polyethylene tibia (apt) retrospectively enrolled and prospectively followed clinical study.The site needed consent to look at the medical record and upon obtaining consent, the site found out that a 2-stage revision was performed due to joint infection.A stryker triathlon press-fit knee was removed; the apt device was used as a spacer.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon press-fit knee - cr size 5 femoral component; cat# unknown; lot# unknown.Simplex p - us full dose 10-pk; cat# 61911010; lot# rmy196.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The following was reported: this patient was part of the triathlon all-polyethylene tibia (apt) retrospectively enrolled and prospectively followed clinical study.The site needed consent to look at the medical record and upon obtaining consent, the site found out that a 2-stage revision was performed due to joint infection.A stryker triathlon press-fit knee was removed; the apt device was used as a spacer.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon cr fem comp #5 l-cem; cat# 5510f501; lot# ccx2e, simplex p - us full dose 10-pk; cat# 61911010; lot# rmy196.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a triathlon tibial component was reported.The event was confirmed via review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a left total knee arthroplasty that became infected.He had previously had a right total knee arthroplasty that was suspected to be infected.Aspiration revealed a cloudy effusion of the right knee and the left knee was definitely infected.The causes of perioperative total knee arthroplasty infection are multifactorial including surgical technique factors such as contamination at the time of surgery, delay in wound healing, and lack of adequate closure.Patient factors such as failure to comply with postoperative instructions as well as activity level and bmi can also be implicated.If the infection is late, seeding of the knee joint from a remote source can be considered.I would not assign any causality to the implant itself." product history review: review of the device history records indicate the 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 lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a left total knee arthroplasty that became infected.He had previously had a right total knee arthroplasty that was suspected to be infected.Aspiration revealed a cloudy effusion of the right knee and the left knee was definitely infected.The causes of perioperative total knee arthroplasty infection are multifactorial including surgical technique factors such as contamination at the time of surgery, delay in wound healing, and lack of adequate closure.Patient factors such as failure to comply with postoperative instructions as well as activity level and bmi can also be implicated.If the infection is late, seeding of the knee joint from a remote source can be considered.I would not assign any causality to the implant itself." the exact cause of the event could not be determined from the information provided.Further information such as pathology reports and patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON #5 CS ALLPOLY 9MM
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15925652
• Report Number: 0002249697-2022-01776
• Device Sequence Number: 17721552
• Product Code: MBH
• UDI-Device Identifier: 07613327043297
• UDI-Public: 07613327043297
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 05/31/2019
• Device Model Number: 5534-A-509
• Device Catalogue Number: 5534A509
• Device Lot Number: 251557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Hispanic
• Patient Race: White