MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-600
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional 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 other similar events for the lot referenced.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.
Event or Problem Description
Patient experienced onset of pain that has progressively worsened over the last 4 months.He experiences stiffness and soreness, and has difficult walking.Sometimes his right knee gives out.X-rays show well positioned implant without signs of loosening.Exam shows hyperextension of 10-15 degrees.10 degrees of varus/valgus opening with palpable crepitus with stress of the collateral ligaments.Leg lengths equal.Note: patient had hyperextension noted at (b)(6) 2016.Tibial subsidence was also found prior to the revision.
Event or Problem Description
Patient experienced onset of pain that has progressively worsened over the last 4 months.He experiences stiffness and soreness, and has difficult walking.Sometimes his right knee gives out.X-rays show well positioned implant without signs of loosening.Exam shows hyperextension of 10-15 degrees.10 degrees of varus/valgus opening with palpable crepitus with stress of the collateral ligaments.Leg lengths equal.Note: patient had hyperextension noted at (b)(6) 2016.Tibial subsidence was also found prior to the revision.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving an triathlon baseplate was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: re pi - which represents a male patient, dob (b)(6) 1950 described as 74 inches tall and weighing 250 pounds.His date of implantation is listed as (b)(6) 2015 and explanation (b)(6) 2021.The event description states:¿.Pain.Worsening over the last 4 months.Exam shows hyperextension of 10-15 degrees, 10 degrees of virus/valgus opening.Tibial subsidence.Found prior to the revision.¿ on (b)(6) 2021 ¿operative report.Revision right total knee replacement, single component, cemented tibia.Pre/post-op diagnosis: instability right total knee.Spinal anesthesia.Findings: instability right knee.Tibial component subsided posteriorly.Instability and hyperextension.Femoral and patellar components well fixed.Tibial component removed.Excellent bone left on tibial surface.Proximal resection with reamer based cutting guide.Medial and lateral augments.Implants cemented into place.Triathlon universal tibia with 5 mm medial and lateral augments and 13 mm stem.Tibial insert 19 mm ts.¿ no clinical or pmh, no primary tka operative report, no imaging studies, no examination of explanted components.While the revision operative report appears to confirm the event description, insufficient data is presented to create a medical report for this case.Device history review: all 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 reported lot.Conclusion: it was reported that the patient knee was revised due to instability.A review of the provided medical records by a clinical consultant rejected and stated that : "while the revision operative report appears to confirm the event description, insufficient data is presented to create a medical report for this case".The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRITANIUM BPLATE TRIATHLON S6
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12446178
• Report Number: 0002249697-2021-01535
• Device Sequence Number: 3722409
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 08/31/2020
• Device Model Number: 5536-B-600
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD7579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 113