MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE3 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5526-B-300
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review of provided medical records.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 information by a clinical consultant indicated: narrative: this inquiry concerns a patient who underwent a primary cementless triathlon total knee arthroplasty in 2015 and was subsequently revised in 2023 for instability.The revision was carried out with a triathlon ts implant.Conclusion of assessment: this patient underwent a cementless primary cruciate retaining triathlon total knee arthroplasty and subsequently developed instability requiring revision approximately eight years later.I can confirm that the primary surgery took place as i was able to examine preoperative and postoperative x-rays.The summary states that a revision was carried out and i am able to confirm the revision since i was able to review an operation report.I do not have any post revision x-rays.The root causes of late instability following primary cruciate retaining total knee arthroplasty are multifactorial and i cannot determine it with certainty for this case.Factors include surgical technique regarding implant positioning and alignment as well as restoration of kinematics and stability and patient factors including activity level and bmi.In this particular case the femoral component was placed posterior to its ideal position and the tibial implant was placed in a greater degree of flexion than ideal.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.Conclusions: it was reported that the patient was revised due to instability and fracture/wear of the triathlon insert.A review of the provided medical records by a clinical consultant indicated that 'in this particular case the femoral component was placed posterior to its ideal position and the tibial implant was placed in a greater degree of flexion than ideal.I would not assign any causality to the implant itself.' no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3: not returned to the manufacturer.
Event or Problem Description
Knee revision.Reason for revision: instability.Update - in this particular case the femoral component was placed posterior to its ideal position and the tibial implant was placed in a greater degree of flexion than ideal.

• Brand Name: TRIATHLON PRIM BEAD PA SZE3 BP
• 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 NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16793261
• Report Number: 0002249697-2023-00405
• Device Sequence Number: 7516129
• Product Code: MBH
• UDI-Device Identifier: 07613327041347
• UDI-Public: 07613327041347
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 5526-B-300
• Device Catalogue Number: 5526B300
• Device Lot Number: AAF4X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 94 KG