MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5520-B-400

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening and pain involving a triathlon baseplate was reported.The event for tibial loosening was confirmed through medical review.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 patient underwent a right total knee arthroplasty in (b)(6) 2018 and required revision for loosening of the tibial component in (b)(6) 2019.A possible second revision of the right knee is pending and the reason for the revision is unknown.The patient's family states that the right knee revision will be into the three months because the surgeon is waiting in order to minimize the risk of blood clots.I can confirm that the patient had a primary right total knee arthroplasty on (b)(6) 2018, and then underwent revision surgery of that knee on (b)(6) 2019.I was able to review the primary and revision operation reports.The patient also underwent a left total knee, arthroplasty, and subsequently also required revision for tibial loosening less than 3 years after surgery.I cannot determine the root cause of these events with certainty.According to the operation reports the tibial components were loose.The causes of loosening of a primary cementless base plate at 18 months and 3 years after the initial procedure are multifactorial including surgical technique, method and efficacy of primary fixation, patient factors such as activity level and bmi and postoperative compliance.Given the information provided, 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 referenced.Conclusions: it was reported that the patient was revised due to loosening of the tibial component and pain.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a right total knee arthroplasty in (b)(6) 2018 and required revision for loosening of the tibial component in (b)(6) 2019.A possible second revision of the right knee is pending and the reason for the revision is unknown.The patient's family states that the right knee revision will be into the three months because the surgeon is waiting in order to minimize the risk of blood clots.I can confirm that the patient had a primary right total knee arthroplasty on (b)(6) 2018, and then underwent revision surgery of that knee on december 2, 2019.I was able to review the primary and revision operation reports.The patient also underwent a left total knee, arthroplasty, and subsequently also required revision for tibial loosening less than 3 years after surgery.I cannot determine the root cause of these events with certainty.According to the operation reports the tibial components were loose.The causes of loosening of a primary cementless base plate at 18 months and 3 years after the initial procedure are multifactorial including surgical technique, method and efficacy of primary fixation, patient factors such as activity level and bmi and postoperative compliance.Given the information provided, 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 return of the devices, primary and revision operative reports as well as 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.H3 other text : device not returned.

Event Description

This pi for the left knee - impending revision (b)(6) 2023 as reported by the patient:: right knee: (b)(6) 2018: primary right knee stryker implant; (b)(6) 2019: revision, right knee, stryker implant - reason unknown; possible second revision of the right knee, date to determine -reason unknown; (b)(6) 2023: daughter confirmed that right knee revision will be in 2-3 months.The surgeon would like to minimize the risk of blood clots by waiting to do the revision.Left knee: (b)(6) 2020:primary left knee stryker implant ; (b)(6) 2022: patient reports pain, a bone scan was performed ; (b)(6) 2023: dr confirmed that her implants ¿fell apart.¿ left knee revision required, revision scheduled for (b)(6) 2023.Daughter is not sure if that is even possible implants falling apart and would like it investigated.(b)(6) 2023: daughter confirmed her mother had revision surgery of the left knee on (b)(6) and she is currently experiencing increased pain since the procedure.Daughter stated her mother's quality life has diminished since the multiple revisions.

Manufacturer Narrative

Reported event: an event regarding loosening and pain involving a triathlon baseplate was reported.The event for tibial loosening was confirmed through medical review.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 64-year-old female patient who underwent bilateral total knee arthroplasties.This patient underwent a right total knee arthroplasty in (b)(6) 2018 and required revision for loosening of the tibial component in (b)(6) 2019.A possible second revision of the right knee is pending and the reason for the revision is unknown.The patient's family states that the right knee revision will be into the three months because the surgeon is waiting in order to minimize the risk of blood clots.I can confirm that the patient had a primary right total knee arthroplasty on (b)(6) 2018, and then underwent revision surgery of that knee on (b)(6) 2019.I was able to review the primary and revision operation reports.The patient also underwent a left total knee, arthroplasty, and subsequently also required revision for tibial loosening less than 3 years after surgery.I cannot determine the root cause of these events with certainty.According to the operation reports the tibial components were loose.The causes of loosening of a primary cementless base plate at 18 months and 3 years after the initial procedure are multifactorial including surgical technique, method and efficacy of primary fixation, patient factors such as activity level and bmi and postoperative compliance.Given the information provided, i would not assign any causality to the implant itself." product history review: review of the device history records indicate 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 referenced.Conclusions: it was reported that the patient was revised due to loosening of the tibial component and pain.A review of the provided medical information by a clinical consultant indicated: " this inquiry concerns a 64-year-old female patient who underwent bilateral total knee arthroplasties.This patient underwent a right total knee arthroplasty in (b)(6) 2018 and required revision for loosening of the tibial component in (b)(6) 2019.A possible second revision of the right knee is pending and the reason for the revision is unknown.The patient's family states that the right knee revision will be into the three months because the surgeon is waiting in order to minimize the risk of blood clots.I can confirm that the patient had a primary right total knee arthroplasty on (b)(6) 2018, and then underwent revision surgery of that knee on (b)(6) 2019.I was able to review the primary and revision operation reports.The patient also underwent a left total knee, arthroplasty, and subsequently also required revision for tibial loosening less than 3 years after surgery.I cannot determine the root cause of these events with certainty.According to the operation reports the tibial components were loose.The causes of loosening of a primary cementless base plate at 18 months and 3 years after the initial procedure are multifactorial including surgical technique, method and efficacy of primary fixation, patient factors such as activity level and bmi and postoperative compliance.Given the information provided, 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 return of the devices, primary and revision operative reports as well as 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.

Event Description

This pi for the left knee - impending revision (b)(6) 2023; as reported by the patient:: right knee: (b)(6) 2018: primary right knee stryker implant (b)(6) 2019: revision, right knee, stryker implant - reason unknown possible second revision of the right knee, date to determine -reason unknown (b)(6) 2023: daughter confirmed that right knee revision will be in 2-3 months.The surgeon would like to minimize the risk of blood clots by waiting to do the revision.Left knee: (b)(6) 2020:primary left knee stryker implant (b)(6) 2022: patient reports pain, a bone scan was performed (b)(6) 2023: dr confirmed that her implants ¿fell apart.¿ left knee revision required, revision scheduled for 9 march 2023.Daughter is not sure if that is even possible implants falling apart and would like it investigated.(b)(6) 2023: daughter confirmed her mother had revision surgery of the left knee on (b)(6) 2023 and she is currently experiencing increased pain since the procedure.Daughter stated her mother's quality life has diminished since the multiple revisions.Update per op report: patient was revised on (b)(6) 2023 due to pain and loosening.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17199693
• MDR Text Key: 317987518
• Report Number: 0002249697-2023-00714
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050325
• UDI-Public: 07613327050325
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5520-B-400
• Device Catalogue Number: 5520-B-400
• Device Lot Number: GAE3LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White