MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BPLATE CEMENTED SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520-B-400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported, "please see letter of the attorney translated below: "on (b)(6) 2019, our client was admitted to the hospital for inpatient treatment and underwent a knee tep implantation (right) due to advanced gonarthrosis.In confidence in the examinations and diagnoses made up to that point, the operation was then performed on our client on (b)(6) 2019, whereby the medical product of the company stryker, model triathlon cs, femur size 4, tibia size 4, 11mm cs inlay was selected as the prosthesis and its size was determined to be size 4.In a letter dated on (b)(6) 2019, 2019, stryker gmbh & co kg informed already at that time about a defectiveness of the triathlon femorales series and recalled a large number of products already placed on the market.Our client, who had previously been implanted with a total endoprosthesis from the series affected by the recall, then experienced complaints in the form of persistent knee pain (right) and restricted movement of the right knee after approximately 2.5 years, starting on (b)(6) 2021.Our client therefore presented to the joint practice on (b)(6) 2021.Since both the pain and the movement restrictions in the right knee persisted, our client presented to the consultation on (b)(6) 2022.Here, an aseptic knee tep loosening (right) was diagnosed.At the same time, this was the first time that a connection between the inserted prosthesis and the complaints could be identified for our client.After the indication for a re-operation with implant change had been given, our client presented herself again for inpatient admission on (b)(6) 2022 on the occasion of the planned knee tep change (right).The replacement of the knee tep was then performed on (b)(6) 2022.A size 3 knee tep was implanted.Intraoperatively, the explantation of the knee prosthesis at the posteromedial condyle revealed a fracture of the tibial support.In accordance with the intraoperatively determined fracture of the tibial support, the expert engineer of the laboratory also assumes a permanent fatigue fracture of the prosthesis.Finally, the knee tep implanted on (b)(6) 2019 caused both the movement restriction and the pain from which our client suffered at least in the period from on (b)(6) 2021 to on (b)(6) 2022.The complaints existing until then were also accompanied by a considerable restriction of household management and coping with everyday life.This was because our client was unable to perform household activities that can only be done while standing or walking due to the painful restriction of movement.".
Additional 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.H3 other text : not available.
Event or Problem Description
The following was reported, "please see letter of the attorney translated below: "on (b)(6) 2019, our client was admitted to the hospital for inpatient treatment and underwent a knee tep implantation (right) due to advanced gonarthrosis.In confidence in the examinations and diagnoses made up to that point, the operation was then performed on our client on (b)(6) 2019, whereby the medical product of the company stryker, model triathlon cs, femur size 4, tibia size 4, 11mm cs inlay was selected as the prosthesis and its size was determined to be size 4.In a letter dated (b)(6) 2019, 2019, stryker gmbh & co kg informed already at that time about a defectiveness of the triathlon femorales series and recalled a large number of products already placed on the market.Our client, who had previously been implanted with a total endoprosthesis from the series affected by the recall, then experienced complaints in the form of persistent knee pain (right) and restricted movement of the right knee after approximately 2.5 years, starting in (b)(6) 2021.Our client therefore presented to the joint practice in (b)(6) 2021.Since both the pain and the movement restrictions in the right knee persisted, our client presented to the consultation on (b)(6) 2022.Here, an aseptic knee tep loosening (right) was diagnosed.At the same time, this was the first time that a connection between the inserted prosthesis and the complaints could be identified for our client.After the indication for a re-operation with implant change had been given, our client presented herself again for inpatient admission on (b)(6) 2022 on the occasion of the planned knee tep change (right).The replacement of the knee tep was then performed on (b)(6) 2022.A size 3 knee tep was implanted.Intraoperatively, the explantation of the knee prosthesis at the posteromedial condyle revealed a fracture of the tibial support.In accordance with the intraoperatively determined fracture of the tibial support, the expert engineer of the laboratory also assumes a permanent fatigue fracture of the prosthesis.Finally, the knee tep implanted on (b)(6) 2019 caused both the movement restriction and the pain from which our client suffered at least in the period from august 2021 to april 2022.The complaints existing until then were also accompanied by a considerable restriction of household management and coping with everyday life.This was because our client was unable to perform household activities that can only be done while standing or walking due to the painful restriction of movement.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an unknown triathlon baseplate 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.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry concerns a patient who underwent a primary cemented triathlon cs total knee arthroplasty and approximately three years later underwent a revision procedure for pain and restricted movement.A fractured base plate was found.I can confirm that a primary procedure was performed since i was able to review the operation report.It was performed by a resident surgeon ostensibly with attending surgeon supervision.I cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to fracture of the tibial baseplate.A review of the provided medical records by a clinician was unable to confirm the event: "i cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report 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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon baseplate 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.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry concerns a patient who underwent a primary cemented triathlon cs total knee arthroplasty and approximately three years later underwent a revision procedure for pain and restricted movement.A fractured base plate was found.I can confirm that a primary procedure was performed since i was able to review the operation report.It was performed by a resident surgeon ostensibly with attending surgeon supervision.I cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I am personally not aware of any recall of a triathlon femoral prosthesis but certainly this may have occurred.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." 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 fracture of the tibial baseplate.A review of the provided medical records by a clinician was unable to confirm the event: "i cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I am personally not aware of any recall of a triathlon femoral prosthesis but certainly this may have occurred.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report 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 or Problem Description
No new information.
Additional Manufacturer Narrative
D4 lot number updated.Reported event: an event regarding crack/fracture involving a triathlon baseplate 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.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry concerns a patient who underwent a primary cemented triathlon cs total knee arthroplasty and approximately three years later underwent a revision procedure for pain and restricted movement.A fractured base plate was found.I can confirm that a primary procedure was performed since i was able to review the operation report.It was performed by a resident surgeon ostensibly with attending surgeon supervision.I cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I am personally not aware of any recall of a triathlon femoral prosthesis but certainly this may have occurred.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant 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 fracture of the tibial baseplate.A review of the provided medical records by a clinician was unable to confirm the event: "i cannot confirm that the revision occurred since i have no documentation including office notes, operation notes or x-rays of the revision.While the attorney alleges a recall of the femoral component, according to the summary it was the tibial baseplate that failed and not the femoral component.I am personally not aware of any recall of a triathlon femoral prosthesis but certainly this may have occurred.I cannot confirm the root cause of this event with certainty.The causes of tibial baseplate fracture approximately three years following implantation are multifactorial including surgical technique factors, especially cementing technique, patient factors including activity level and bmi and implant factors.If preferential cementing was carried out on the lateral side with inadequate support on the medial side, a cantilever effect could occur resulting in a stress fracture of the base plate." further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report 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 or Problem Description
No new information.

• Brand Name: TRIATHLON PRIM TIB BPLATE CEMENTED SZ 4
• 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 NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17305884
• Report Number: 0002249697-2023-00766
• Device Sequence Number: 15079543
• Product Code: MBH
• UDI-Device Identifier: 07613327050325
• UDI-Public: 07613327050325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/07/2026

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: 10/17/2023
• Device Catalogue Number: 5520-B-400
• Device Lot Number: ESY6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 08/07/2025; 12/10/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/07/2023; 09/02/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: 51 YR
• Patient Sex: Female