MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5537-G-413

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

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.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.The following devices were also listed in this report: device name#tri ts femur sz4 left ; cat#5512-f-401 ; lot#buz4s, device name#triathlon fem cone aug sz 4l ; cat#5549-a-341 ; lot#d5t5, device name#tri ts baseplate size 4 ; cat#5521-b-400 ; lot#bxt4xa, device name#riathlon sym cone aug sz b ; cat#5549-a-120 ; lot#epa6.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient presented with left knee pain, inability to lift leg, increased knee swelling, pain with initiation of weight bearing, stiffness of the knee with attempted range of motion, burning with range of motion.Tibial insert was revised.

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was not confirmed.Method & results product evaluation and results: not performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "this case concerns a patient who underwent a revision total knee arthroplasty and then developed pain and swelling and other symptoms and subsequently underwent a revision procedure for debridement, revision of a loose patella component and repair of the soft tissues medially and exchange of the tibial polyethylene.I can confirm that this revision procedure took place as i was able to review the operation report and review a series of x-rays.I can confirm that the patient did have a revision total knee arthroplasty in place prior to the second revision.The x-rays that i reviewed could be consistent with loosening of both the femoral and tibial components but no mention was made during the operation report of any testing of those components, although under the operative findings the surgeon stated that the femur was well fixed.The causes of patella loosening and disruption of the medial retinaculum are multifactorial.These include surgical technique factors such as cementing techniques and patella preparation and insertion techniques and proper closure of the retinaculum.There are also patient factors including bmi and activity level and possible trauma either reported or unreported.Patient compliance in the immediate postop period can also contribute.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.Conclusion: a review of medical records with a clinical consultant indicated "this case concerns a patient who underwent a revision total knee arthroplasty and then developed pain and swelling and other symptoms and subsequently underwent a revision procedure for debridement, revision of a loose patella component and repair of the soft tissues medially and exchange of the tibial polyethylene.I can confirm that this revision procedure took place as i was able to review the operation report and review a series of x-rays.I can confirm that the patient did have a revision total knee arthroplasty in place prior to the second revision.The x-rays that i reviewed could be consistent with loosening of both the femoral and tibial components but no mention was made during the operation report of any testing of those components, although under the operative findings the surgeon stated that the femur was well fixed.The causes of patella loosening and disruption of the medial retinaculum are multifactorial.These include surgical technique factors such as cementing techniques and patella preparation and insertion techniques and proper closure of the retinaculum.There are also patient factors including bmi and activity level and possible trauma either reported or unreported.Patient compliance in the immediate postop period can also contribute.I would not assign any causality to the implant itself." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, photos etc 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

Onset date (b)(6) 2021 patient seen for complaints of left knee pain, inability to lift left leg, increased left knee swelling, pain with initiation of weight bearing, stiffness of the knee with attempted range of motion, burning with range of motion.They rate their pain 10/10 in severity with activity and 7/10 in severity at rest, pain is present at night and admit to anterior knee pain with ascending and descending stairs.They have been participating in physician therapy for chronic low back pain and history of left sided sciatic.Patient being worked up for concerns of patellar tilt and aspectic loosening.Revision (b)(6) 2022.Per response: please confirm: was only the insert revised? "tibial insert revised." are the reported device(s) available for return? if not, why not?: "requested from study coordinator subject signed icf to confirm device retrieval.Once confirmed will provide an update." update as per investigation conclusion/med review: ".Revision procedure for debridement, revision of a loose patella component and repair of the soft tissues medially and exchange of the tibial polyethylene.".

Event Description

Onset date (b)(6) 2021 patient seen for complaints of left knee pain, inability to lift left leg, increased left knee swelling, pain with initiation of weight bearing, stiffness of the knee with attempted range of motion, burning with range of motion.They rate their pain 10/10 in severity with activity and 7/10 in severity at rest, pain is present at night and admit to anterior knee pain with ascending and descending stairs.They have been participating in physician therapy for chronic low back pain and history of left sided sciatic.Patient being worked up for concerns of patellar tilt and aspectic loosening.Revision (b)(6) 2022.Per response: please confirm: was only the insert revised? "tibial insert revised.".Are the reported device(s) available for return? if not, why not?: "requested from study coordinator subject signed icf to confirm device retrieval.Once confirmed will provide an update.".Update as per investigation conclusion/med review: ".Revision procedure for debridement, revision of a loose patella component and repair of the soft tissues medially and exchange of the tibial polyethylene.".

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: "these product inquiries concerning a patient who underwent a primary total knee arthroplasty in 2008.The patient was then revised on (b)(6) 2019 for loose femoral and tibial components and a fractured femoral stem.The patient was then revised again on (b)(6) 2022 due to a loose patella component with repair of the medial soft tissues and a polyethylene exchange.The patient subsequently developed an infection and underwent debridement and polyethylene exchange on (b)(6) 2024.The root cause of loosening of the femoral and tibial components and fracture of the femoral stem several years after the index operation cannot be determined with certainty.The causes are multifactorial including surgical technique, especially in the cementing technique, patient activity level and bmi.The cause of the fractured stem cannot be determined with certainty.The explanted components must be submitted to stryker engineers for analysis and evaluation.I cannot confirm the original operation in 2008 since i don't have any information about it.I can confirm that the patient had the initial revision procedure in 2019 for the loose components and broken femoral stem since i was able to review the operation report.I can also confirm that the patient had the second revision in 2022 since i was able to review the operation report.The causes of aseptic loosening of the patella as well as disruption of the medial arthrotomy are multifactorial including surgical technique, especially in the manner of cementing and insertion of the patella component, the adequacy of the medial retinaculum repair, possible trauma, patient activity level and bmi.I would not assign any causality to the patella component itself.The explanted patella component should be submitted to stryker engineers for analysis and evaluation.I can also confirm the revision and irrigation and debridement of the knee, the third revision, in 2024 since i was able to review the operation report.I cannot determine the root cause of periprosthetic infection with certainty.The causes of periprosthetic joint infection are multifactorial including possible wound contamination, possible seeding from a remote site, and also contributing can be the fact that the patient had multiple operations.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.Conclusion: "these product inquiries concerning a patient who underwent a primary total knee arthroplasty in 2008.The patient was then revised on (b)(6) 20, 2019 for loose femoral and tibial components and a fractured femoral stem.The patient was then revised again on (b)(6) 2022 due to a loose patella component with repair of the medial soft tissues and a polyethylene exchange.The patient subsequently developed an infection and underwent debridement and polyethylene exchange on (b)(6) 15, 2024.The root cause of loosening of the femoral and tibial components and fracture of the femoral stem several years after the index operation cannot be determined with certainty.The causes are multifactorial including surgical technique, especially in the cementing technique, patient activity level and bmi.The cause of the fractured stem cannot be determined with certainty.The explanted components must be submitted to stryker engineers for analysis and evaluation.I cannot confirm the original operation in 2008 since i don't have any information about it.I can confirm that the patient had the initial revision procedure in 2019 for the loose components and broken femoral stem since i was able to review the operation report.I can also confirm that the patient had the second revision in 2022 since i was able to review the operation report.The causes of aseptic loosening of the patella as well as disruption of the medial arthrotomy are multifactorial including surgical technique, especially in the manner of cementing and insertion of the patella component, the adequacy of the medial retinaculum repair, possible trauma, patient activity level and bmi.I would not assign any causality to the patella component itself.The explanted patella component should be submitted to stryker engineers for analysis and evaluation.I can also confirm the revision and irrigation and debridement of the knee, the third revision, in 2024 since i was able to review the operation report.I cannot determine the root cause of periprosthetic infection with certainty.The causes of periprosthetic joint infection are multifactorial including possible wound contamination, possible seeding from a remote site, and also contributing can be the fact that the patient had multiple operations.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

Onset date (b)(6) 2021 patient seen for complaints of left knee pain, inability to lift left leg, increased left knee swelling, pain with initiation of weight bearing, stiffness of the knee with attempted range of motion, burning with range of motion.They rate their pain 10/10 in severity with activity and 7/10 in severity at rest, pain is present at night and admit to anterior knee pain with ascending and descending stairs.They have been participating in physician therapy for chronic low back pain and history of left sided sciatic.Patient being worked up for concerns of patellar tilt and aspectic loosening.Revision (b)(6) 2022.Per response: ¿ please confirm: was only the insert revised? "tibial insert revised." ¿ are the reported device(s) available for return? if not, why not?: "requested from study coordinator subject signed icf to confirm device retrieval.Once confirmed will provide an update." update as per investigation conclusion/med review: ".Revision procedure for debridement, revision of a loose patella component and repair of the soft tissues medially and exchange of the tibial polyethylene.".

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was not confirmed.Method & results -product evaluation and results: not performed as the device was not returned.-clinician review: "these product inquiries concerning a patient who underwent a primary total knee arthroplasty in 2008.The patient was then revised on (b)(6) 2019 for loose femoral and tibial components and a fractured femoral stem.The patient was then revised again on (b)(6) 2022 due to a loose patella component with repair of the medial soft tissues and a polyethylene exchange.The patient subsequently developed an infection and underwent debridement and polyethylene exchange on (b)(6) 2024.The root cause of loosening of the femoral and tibial components and fracture of the femoral stem several years after the index operation cannot be determined with certainty.The causes are multifactorial including surgical technique, especially in the cementing technique, patient activity level and bmi.The cause of the fractured stem cannot be determined with certainty.The explanted components must be submitted to stryker engineers for analysis and evaluation.I cannot confirm the original operation in 2008 since i don't have any information about it.I can confirm that the patient had the initial revision procedure in 2019 for the loose components and broken femoral stem since i was able to review the operation report.I can also confirm that the patient had the second revision in 2022 since i was able to review the operation report.The causes of aseptic loosening of the patella as well as disruption of the medial arthrotomy are multifactorial including surgical technique, especially in the manner of cementing and insertion of the patella component, the adequacy of the medial retinaculum repair, possible trauma, patient activity level and bmi.I would not assign any causality to the patella component itself.The explanted patella component should be submitted to stryker engineers for analysis and evaluation.I can also confirm the revision and irrigation and debridement of the knee, the third revision, in 2024 since i was able to review the operation report.I cannot determine the root cause of periprosthetic infection with certainty.The causes of periprosthetic joint infection are multifactorial including possible wound contamination, possible seeding from a remote site, and also contributing can be the fact that the patient had multiple operations.Per addendum "based upon the new documents and information provided, my confirmation of events and my conclusion of assessment is unchanged." -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.Conclusion: "these product inquiries concerning a patient who underwent a primary total knee arthroplasty in 2008.The patient was then revised on (b)(6) 2019 for loose femoral and tibial components and a fractured femoral stem.The patient was then revised again on (b)(6) 2022 due to a loose patella component with repair of the medial soft tissues and a polyethylene exchange.The patient subsequently developed an infection and underwent debridement and polyethylene exchange on (b)(6) 2024.The root cause of loosening of the femoral and tibial components and fracture of the femoral stem several years after the index operation cannot be determined with certainty.The causes are multifactorial including surgical technique, especially in the cementing technique, patient activity level and bmi.The cause of the fractured stem cannot be determined with certainty.The explanted components must be submitted to stryker engineers for analysis and evaluation.I cannot confirm the original operation in 2008 since i don't have any information about it.I can confirm that the patient had the initial revision procedure in 2019 for the loose components and broken femoral stem since i was able to review the operation report.I can also confirm that the patient had the second revision in 2022 since i was able to review the operation report.The causes of aseptic loosening of the patella as well as disruption of the medial arthrotomy are multifactorial including surgical technique, especially in the manner of cementing and insertion of the patella component, the adequacy of the medial retinaculum repair, possible trauma, patient activity level and bmi.I would not assign any causality to the patella component itself.The explanted patella component should be submitted to stryker engineers for analysis and evaluation.I can also confirm the revision and irrigation and debridement of the knee, the third revision, in 2024 since i was able to review the operation report.I cannot determine the root cause of periprosthetic infection with certainty.The causes of periprosthetic joint infection are multifactorial including possible wound contamination, possible seeding from a remote site, and also contributing can be the fact that the patient had multiple operations.Per addendum "based upon the new documents and information provided, my confirmation of events and my conclusion of assessment is unchanged." 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: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16094112
• MDR Text Key: 306599040
• Report Number: 0002249697-2023-00006
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327027242
• UDI-Public: 07613327027242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 5537-G-413
• Device Catalogue Number: 5537-G-413
• Device Lot Number: 7R039Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 02/09/2024; 03/18/2024
• Supplement Dates FDA Received: 03/13/2023; 03/05/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native