MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON PS INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Unstable (1667)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding instability involving an unknown triathlon insert was reported.The event was 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 records by a clinical consultant indicated: "this 68 year old female had her initial knee replacement in 2009, a revision of that knee for instability with a thicker spacer in 2016 and then again, another revision in 2023 for instability and then six months later the knee became unstable again requiring revision to a ts component.I can confirm that the patient required re-revision in (b)(6) 2023 since i was able to see the original stryker stickers of the ts implant.The root cause of these events cannot be determined with absolute certainty.The causes of recurrent instability of a primary total knee, requiring a thicker spacer, then a posteriorly stabilized component and then a ts component are multi-factorial including surgical technique, patient soft tissue quality, patient activity level and bmi, and possible trauma although none was mentioned in this summary.In the absence of any breakage or damage to her implants, i would not assign any causality to any of the implants." -product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported that the patient was revised due to pain, swelling, and instability.A review of the provided medical records by a clinical consultant indicated: "this 68 year old female had her initial knee replacement in 2009, a revision of that knee for instability with a thicker spacer in 2016, and then again, another revision in 2023 for instability, and then six months later the knee became unstable again requiring revision to a ts component.I can confirm that the patient required re-revision in (b)(6) 2023 since i was able to see the original stryker stickers of the ts implant.However, i do not have the operation report or office notes after her latest revision.I do not have any x-rays following the rerevision.The root cause of these events cannot be determined with absolute certainty.The causes of recurrent instability of a primary total knee, requiring a thicker spacer, then a posteriorly stabilized component and then a ts component are multi-factorial including surgical technique, patient soft tissue quality, patient activity level and bmi, and possible trauma although none was mentioned in this summary.In the absence of any breakage or damage to her implants, i would not assign any causality to any of the implants."the exact cause of the event could not be determined because insufficient information was provided.Further information such as device information and return of the device re 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.The following devices were also listed in this report: device name#unknown triathlon size 2 triathlon baseplate ; cat#unknown ; lot#unknown.Device name#unknown triathlon ps left femur ; cat#unknown ; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's left knee was revised due to pain, swelling, and instability.Surgeon converted the patient's ps knee to a ts knee.

• Brand Name: UNKNOWN TRIATHLON PS INSERT
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17727410
• MDR Text Key: 323148763
• Report Number: 0002249697-2023-01024
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2023

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG