MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 19MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5565-S-019
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Postoperative diagnosis: the patient had a history of left knee replacement (outside of cors scope).Patient underwent knee revision for mechanical problem (b)(6) 2017.The patella was retained.The patient underwent left knee replacement revision of femoral components and polyethylene (b)(6) 2019.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a triathlon stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: the med review addendum indicated " confirmation of event: i can confirm that the patient underwent a revision left total knee replacement on (b)(6) 2017 since i was able to review the operation report.I can also confirm that the patient underwent another revision of that left total replacement with revision of both components on (b)(6) 2019 for now location and stability since i was able to review the operation report.Although i have not seen the operational report, i can presumably confirm that the patient had another revision on (b)(6) 2020 since i was able to review the office notes following the procedure documenting her surgical procedure and date.Root cause analysis: the root cause of these events, malrotation and instability as well as femoral and tibial loosening, cannot be determined with certainty.As for now limitation, the root cause is virtually always surgical technique with placement of components outside of the proper rotation parameters.Regarding instability, factors include surgical technique in the way that the need was balanced in flexion and extension and in mid-range flexion as well as restoration of the proper kinematics of the knee.Patient factors can also attribute including stretching out of the ligaments, patient's lifestyle, activity level and bmi.Trauma can also play a role.Regarding femoral and tibial loosening, causative factors include surgical technique, especially in the implantation, cementing and preparation of the bone for the implants, as well as the local bone quality.Patient factors including lifestyle, activity level and bmi, as well as the possibility of trauma can also be contributing.I would not attribute any causality to the implants themselves for these particular issues." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the med review addendum indicated " confirmation of event: i can confirm that the patient underwent a revision left total knee replacement on (b)(6) 2017 since i was able to review the operation report.I can also confirm that the patient underwent another revision of that left total replacement with revision of both components on (b)(6) 2019 for now location and stability since i was able to review the operation report.Although i have not seen the operational report, i can presumably confirm that the patient had another revision on (b)(6) 2020 since i was able to review the office notes following the procedure documenting her surgical procedure and date.Root cause analysis: the root cause of these events, malrotation and instability as well as femoral and tibial loosening, cannot be determined with certainty.As for now limitation, the root cause is virtually always surgical technique with placement of components outside of the proper rotation parameters.Regarding instability, factors include surgical technique in the way that the need was balanced in flexion and extension and in mid-range flexion as well as restoration of the proper kinematics of the knee.Patient factors can also attribute including stretching out of the ligaments, patient's lifestyle, activity level and bmi.Trauma can also play a role.Regarding femoral and tibial loosening, causative factors include surgical technique, especially in the implantation, cementing and preparation of the bone for the implants, as well as the local bone quality.Patient factors including lifestyle, activity level and bmi, as well as the possibility of trauma can also be contributing.I would not attribute any causality to the implants themselves for these particular issues." 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.
Event or Problem Description
Postoperative diagnosis: the patient had a history of left knee replacement (outside of cors scope).Patient underwent knee revision for mechanical problem (b)(6) 2017.The patella was retained.The patient underwent left knee replacement revision of femoral components and polyethylene (b)(6) 2019.

• Brand Name: TRI PRESS-FIT STEM 19MM X 100MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: 8825981
• Report Number: 0002249697-2019-02660
• Device Sequence Number: 3147067
• Product Code: MBH
• UDI-Device Identifier: 07613327026832
• UDI-Public: 07613327026832
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 04/30/2022
• Device Catalogue Number: 5565-S-019
• Device Lot Number: 0056015K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White