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

Catalog Number 5520-B-400

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 04/08/2019

Event Type  Injury  

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 Description

Mal-rotated tibial tray loose.Rep reported a right knee revision.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed by clinician review.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 information by a clinical consultant indicated: no x-rays are available for review and no examination of explanted components.The description of the x-rays on the march 6, 2019 consult note, ¿looks like a cementless tibial tray¿, which suggests inadequate cement technique, which may have resulted in the tibial component subsiding into varus in this obese patient.There is no evidence of factors associated with implant design, manufacturing or materials having contributed to this clinical situation.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: loosening of the triathlon baseplate was caused by caused by migration/ subsidence, i.E.The baseplate migrated to 5° of varus.The clinical consultant noticed that ¿looks like a cementless tibial tray¿, which suggests inadequate cement technique, which may have resulted in the tibial component subsiding into varus in this obese patient.There is no evidence of factors associated with implant design, manufacturing or materials having contributed to this clinical situation.Also, as reported patient fell on 24 october 2018 and hit both knees on floor, which could contribute to the loosening/ subsidence of the baseplate.The exact cause of the event could not be determined because insufficient information was provided.Further information such as serial x-rays and examination of explanted components are 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.

Event Description

Mal-rotated tibial tray loose.Rep reported a right knee revision.*(b)(6) 2019 qs, update based on the medical review: on (b)(6) 2019 a consultation notes, ¿the patient complains of a painful right tka ¿ six over ten ¿ present three months ¿ fell october 24, 2018 ¿ fractured left foot ¿ hit both knees on floor ¿ pain onset with the current event is (b)(6) 2018.¿.X-ray of the right knee demonstrates a ¿posterior stabilized total knee arthroplasty ¿ lucent line under what looks like cementless tibial tray ¿ migrated to 5° of varus ¿ no ¿ loosening of femoral or patella ¿¿ on (b)(6) 2019 a revision of the right tibial tray was performed for a pre- and post- operative diagnosis of ¿malaligned loose tibial tray¿.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8583616
• MDR Text Key: 144179168
• Report Number: 0002249697-2019-01856
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050325
• UDI-Public: 07613327050325
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 5520-B-400
• Device Lot Number: KYSGA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 117