MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BPLATE CEMENTED SZ 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520-B-600
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
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.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# simplex p - us tobra fd 10-pk; cat# 61979010; lot# mje080, device name# triathlon ps fem component cemented; cat# 5515-f-602; lot# hav3ua, device name# triathlon ps x3 tibial insert; cat# 5532-g-609-e; lot# mv13ve, device name# triathlon asymmetric x3 patella; cat# 5551-g-320-e; lot# arp9, device name# simplex p - us tobra fd 10-pk; cat# 61979010; lot# mcf024, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Pt.Reported; had a total right knee replacement on (b)(6) 2024 and it's been seven months and one day and it's getting worse and worse and worse.The doctor told him they all make noise like that.The doctor stated there could be too much space which may have caused looseness.Do i need help to solve this problem before he operate me again.Pt.Wants to know if the part was defective or it was oversized or it's not installed right.Audible clicking noise, swelling pain and burning sensation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The following devices were also listed in this report: device name# triathlon ps fem component cemented; cat# 5515-f-602; lot# hav3ua.Device name# triathlon ps x3 tibial insert; cat# 5532-g-609-e; lot# mv13ve.Device name# triathlon asymmetric x3 patella; cat# 5551-g-320-e; lot# arp9.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 instability involving a triathlon baseplate was reported.The event was confirmed through a medical review of clinical data.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following: 'i can confirm that the patient had a cemented triathlon total knee arthroplasty since i was able to review the operation report.I can also confirm that there are abnormal noises emanating from his knee based on the audio tapes that were sent with this inquiry.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of pain, swelling, audible clicking, scratching, and other noises emanating from within a total knee arthroplasty are multifactorial.At this point it does not seem likely that the patient has any internal arrangement such as a fracture of the polyethylene or some other type of implant dysfunction.The patient's symptoms and signs are one of an unstable or overly lax knee.Having said that posteriorly stabilized knees almost always are accompanied by audible clicks and noises due to the cam and post mechanism.It would be unlikely for the patient to have contributed by way of lifestyle, activity level or bmi and absent any proof otherwise, i would not assign any causality to the implant itself.Product history review: review of the device history records indicate 08 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: the patient reported audible clicking noise, swelling pain, and burning sensation.A review of the provided medical records by a clinical consultant stated the following: 'i can confirm that the patient had a cemented triathlon total knee arthroplasty since i was able to review the operation report.I can also confirm that there are abnormal noises emanating from his knee based on the audio tapes that were sent with this inquiry.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of pain, swelling, audible clicking, scratching, and other noises emanating from within a total knee arthroplasty are multifactorial.At this point it does not seem likely that the patient has any internal arrangement such as a fracture of the polyethylene or some other type of implant dysfunction.The patient's symptoms and signs are one of an unstable or overly lax knee.Having said that posteriorly stabilized knees almost always are accompanied by audible clicks and noises due to the cam and post mechanism.It would be unlikely for the patient to have contributed by way of lifestyle, activity level or bmi and absent any proof otherwise, i would not assign any causality to the implant itself.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM TIB BPLATE CEMENTED SZ 6
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 22025586
• Report Number: 0002249697-2025-00509
• Device Sequence Number: 9390702
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Catalogue Number: 5520-B-600
• Device Lot Number: IZY4OA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian