MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 RM/LL -10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-220

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were two similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Medical records provided for legal pi have indicated additional treatments/revisions the patient underwent.This pi is for a manipulation under anesthesia (mua) the patient underwent on (b)(6) 2015 due to reported stiffness the patient was experiences after implantation of triathlon pkr components in her right knee.Excerpt from medical review: "on (b)(6) 2015, at 3-months follow-up, right knee flexion of only 100° was reported despite vigorous physical therapy.No further progress in knee flexion and pain reduction was obtained and consequently on (b)(6) 2015, a manipulation under anaesthesia (mua) of the right knee was performed under the diagnosis of arthrofibrosis achieving some 155° of knee flexion.".

Manufacturer Narrative

An event regarding manipulation under anesthetic due to arthrofibrosis & range of motion (rom) involving a triathlon partial insert was reported.The event was confirmed based on clinician review of the medical records provided.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: arthroeibrosis is a frequent complication of knee arthroplasty.The knee is a supereicially located joint that is fully surrounded by a complex soft tissue envelope composed of joint capsule, ligaments, tendons and muscles all located close under the skin.All these structures play an important role in the functionality of the knee and represent together a large surface area with subtle sliding mechanisms between them during knee elexion.Because the knee requires extensile surgical exposure for a prosthesis to be implanted, it does not surprise that scar formation in any of these soft tissue components may lead to impairment of the knee function.Causes for poor rom are multi-factorial but can grossly be categorised into patient related factors and surgery related factors.From the literature, there is fair consensus as to patient related factors.Factors that are signieicantly associated with a stiff or painful outcome include female sex, higher body mass index, previous knee surgery, patients on disability, diabetes mellitus, pulmonary disease and/or depression.From a surgical procedure perspective, there are many factors potentially further contributing to poor functional outcome regarding rom.Among these are malposition of the components, especially in the sagittal plane; oversizing at the patello- femoral or tibio-femoral joint spaces; retaining posterior osteophytes; and persisting with a tight posterior cruciate ligament.Because there are no x-rays available for review, procedure-related factors regarding potential malposition of devices cannot be excluded until x-ray proof of contrary.With modern total knee replacement devices, there are no known device related factors that might carry by itself a relationship with poor functional outcome of the knee.The problem may affect any type of knee, cr or ps, cemented or uncemented irrespective of design or manufacturer.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: early postoperative scar tissue formation around the triathlon pkr components contributed to poor knee functionality requiring manipulation under anaesthesia to release the scar adhesions in the knee and normalise knee elexion.Does the review identify any procedural related factors that contributed to the event? arthroeibrosis a ¿normal¿ complication of any knee arthroplasty caused by scar formation in the soft tissues around the knee devices.Does the review identify any patient related factors that contributed to the event? none signieicant.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.

Event Description

Medical records provided for legal pi have indicated additional treatments/revisions the patient underwent.This pi is for a manipulation under anesthesia (mua) the patient underwent on (b)(6) 2015 due to reported stiffness the patient was experiences after implantation of triathlon pkr components in her right knee.Excerpt from medical review: "on (b)(6) 2015, at 3- months follow-up, right knee flexion of only 100° was reported despite vigorous physical therapy.No further progress in knee flexion and pain reduction was obtained and consequently on (b)(6) 2015, a manipulation under anaesthesia (mua) of the right knee was performed under the diagnosis of arthrofibrosis achieving some 155° of knee flexion.".

• Brand Name: TRIATHLON PKR INSERT X3 #2 RM/LL -10MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9329152
• MDR Text Key: 166935644
• Report Number: 0002249697-2019-03771
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327015881
• UDI-Public: 07613327015881
• Combination Product (y/n): N
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 5630-G-220
• Device Lot Number: MJRYE1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR