MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #2 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F202

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Revised a right triathlon femur and insert due to femoral loosening.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text: device not returned to the manufacturer.

Event Description

Revised a right triathlon femur and insert due to femoral loosening.

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon femoral component 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 medical records by clinician indicated "cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.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.A review of medical records by clinician indicated "cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.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: TRIATHLON CR FEM COMP #2 R-CEM
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18779483
• MDR Text Key: 336234746
• Report Number: 0002249697-2024-00294
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040241
• UDI-Public: 07613327040241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 12/31/2021
• Device Catalogue Number: 5510F202
• Device Lot Number: BTJ2B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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: 62 YR
• Patient Sex: Female