MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-413

Device Problems Unstable (1667); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.Based on the medical review osteolysis, instability and rom were also identified.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.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant revealed: "an infectious complication developed in this knee arthroplasty patient of the femoral as well as tibial knee device with symptoms present ever since time of implantation and progressive loss of knee functionality, instability, deformity and gross loosening of devices requiring a two-stage exchange procedure with at first component removal plus spacer implantation and secondary reconstruction with depuy revision devices.The fact that bacterial cultures prior to or during revision were negative is far from rare given current limitations in laboratory technique while the simultaneous presence of typical clinical symptoms, positive infection lab parameters and surgical findings still allow to establish a final diagnosis of deep joint infection with an adequate level of evidence.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.Conclusion: due to the absence of a positive culture prior to revision and no serial x-rays, the event was not confirmed.Based on the medical review, an infectious complication developed in this knee arthroplasty patient of the femoral as well as tibial knee device with symptoms present ever since time of implantation and progressive loss of knee functionality, instability, deformity and gross loosening of devices requiring a two-stage exchange procedure with at first component removal plus spacer implantation and secondary reconstruction with depuy revision devices.The fact that bacterial cultures prior to or during revision were negative is far from rare given current limitations in laboratory technique while the simultaneous presence of typical clinical symptoms, positive infection lab parameters and surgical findings still allow to establish a final diagnosis of deep joint infection with an adequate level of evidence.It was determined that infection is primarily a procedure-related complication with sometimes additional patient-related risk factors, i.E.Diabetes mellitus and obesity (bmi > 35).No device-related factors are associated with any of the implanted devices consistent with type of failure.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "loose right total knee rule out septic loosening." updated on 08-aug-2019 by qs based on medical review: [.] "at 1-year post primary, on (b)(6) 2013, patient presented with sudden calf pain and swelling." [.] "two years went by until on (b)(6) 2015, patient presented again with progressive knee pain on weight-bearing with numbness and unsteady feelings in the knee, still requiring cane support for walking.Knee flexion had decreased to 90° with a still stable knee as reported." [.] "a few months later, in (b)(6) 2015, knee functionality had further decreased to 75° of flexion with difficulty extending the knee and new stiffness complaints."[.] "on (b)(6) 2017, patient presented again with a progressive valgus deformity of the right knee and limited flexion/extension range of 5° - 90°.Swelling of the knee was present with pain on both medial and lateral side of the right knee.The knee was unstable in valgus.An x-ray of the right knee was reported to show severe osteolysis along anterior and posterior flanges of the femoral component with gross loosening and 20° of valgus deformity while on the tibial side also radiolucent lines were reported to suspect tibial device loosening.Infection parameters were significantly elevated with esr (erythrocyte sedimentation rate) of 60-mm and crp (c-reactive protein) of 24-mg." [.] "right knee revision surgery was performed on (b)(6) 2017.Gross loosening with major osteolysis and abundant granulation tissue was confirmed on the femoral side with also a loose tibial baseplate." [.] "with still a major suspicion for infection based on clinical picture, lab and intraoperative findings." [.] "patella was resurfaced with a low profile patellar device, peri-operative protection with antibiotic.".

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "loose right total knee rule out septic loosening." * updated on 08-aug-2019 by qs based on medical review: "at 1-year post primary, on (b)(6) 2013, patient presented with sudden calf pain and swelling." "two years went by until on (b)(6) 2015, patient presented again with progressive knee pain on weight- bearing with numbness and unsteady feelings in the knee, still requiring cane support for walking.Knee flexion had decreased to 90° with a still stable knee as reported." "a few months later, in (b)(6) 2015, knee functionality had further decreased to 75° of flexion with difficulty extending the knee and new stiffness complaints."on (b)(6) 2017, patient presented again with a progressive valgus deformity of the right knee and limited flexion/extension range of 5° - 90°.Swelling of the knee was present with pain on both medial and lateral side of the right knee.The knee was unstable in valgus.An x-ray of the right knee was reported to show severe osteolysis along anterior and posterior flanges of the femoral component with gross loosening and 20° of valgus deformity while on the tibial side also radiolucent lines were reported to suspect tibial device loosening.Infection parameters were significantly elevated with esr (erythrocyte sedimentation rate) of 60-mm and crp (c- reactive protein) of 24-mg." "right knee revision surgery was performed on (b)(6) 2017.Gross loosening with major osteolysis and abundant granulation tissue was confirmed on the femoral side with also a loose tibial baseplate." "with still a major suspicion for infection based on clinical picture, lab and intraoperative findings." "patella was resurfaced with a low profile patellar device, peri-operative protection with antibiotic.".

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.Based on the medical review osteolysis, instability and rom were also identified.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.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant revealed: "an infectious complication developed in this knee arthroplasty patient of the femoral as well as tibial knee device with symptoms present ever since time of implantation and progressive loss of knee functionality, instability, deformity and gross loosening of devices requiring a two-stage exchange procedure with at first component removal plus spacer implantation and secondary reconstruction with competitor revision devices.The fact that bacterial cultures prior to or during revision were negative is far from rare given current limitations in laboratory technique while the simultaneous presence of typical clinical symptoms, positive infection lab parameters and surgical findings still allow to establish a final diagnosis of deep joint infection with an adequate level of evidence.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.Conclusion: due to the absence of a positive culture prior to revision and no serial x-rays, the event was not confirmed.Based on the medical review, an infectious complication developed in this knee arthroplasty patient of the femoral as well as tibial knee device with symptoms present ever since time of implantation and progressive loss of knee functionality, instability, deformity and gross loosening of devices requiring a two-stage exchange procedure with at first component removal plus spacer implantation and secondary reconstruction with competitor revision devices.The fact that bacterial cultures prior to or during revision were negative is far from rare given current limitations in laboratory technique while the simultaneous presence of typical clinical symptoms, positive infection lab parameters and surgical findings still allow to establish a final diagnosis of deep joint infection with an adequate level of evidence.It was determined that infection is primarily a procedure-related complication with sometimes additional patient-related risk factors, i.E.Diabetes mellitus and obesity (bmi > 35).No device-related factors are associated with any of the implanted devices consistent with type of failure.No further investigation for this event is required 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 X3 TIBIAL 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
• MDR Report Key: 8959622
• MDR Text Key: 161324243
• Report Number: 0002249697-2019-03072
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050509
• UDI-Public: 07613327050509
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: 08/31/2011
• Device Catalogue Number: 5530-G-413
• Device Lot Number: MKM1JY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR