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

Catalog Number 5620-B-202

Device Problems Mechanical Problem (1384); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 06/23/2014

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: triathlon pkr femur #2 rm/ll; cat# 5610-f-202; lot# khpj.Triathlon pkr insert x3 #2 rm/ll -8mm; cat# 5630-g-228; lot# mnexmm.Speedset-us full dose 10 pk; cat# 6192-1-010; lot# diu024.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Stryker pkr device failed.Patient has been in constant pain and have been suffering since the day after surgery back in 2014.

Manufacturer Narrative

Corrected data: previously reported speedset-us full dose 10 pk; cat# 6192-1-010; lot# diu024 was updated to simplex p speedset full dose 1 pack; cat# 6192-1-001; lot# remained unchanged.An event regarding malposition involving a triathlon pkr baseplate #2 rm/ll was reported.The event was confirmed.Method & results: -device evaluation could not be performed as the subject device was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: post-op x-ray of partial knee demonstrates less than optimal positioning of the components which likely resulting in requirement to convert to total knee in less than 2 years.-device history review could not be performed as no lot information was provided -complaint history review: a complaint history review was not performed as no device specific failure modes were identified.Conclusions: the clinician indicated that the post-op x-ray of partial knee demonstrates less than optimal positioning of the components.However, the exact cause of the event could not be determined.Further information such as revision operative report and examination of 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, this investigation will be reopened.

Event Description

Stryker pkr device failed.Patient has been in constant pain and have been suffering since the day after surgery back in 2014.

Manufacturer Narrative

An event regarding malposition involving a triathlon pkr femur #2 rm/ll was reported.The event was confirmed.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: on (b)(6) 2014 he underwent a primary right medial uni-compartmental knee arthroplasty for a diagnosis of right knee medial arthritis.On a visit of (b)(6) 2015 it was noted, "intermittent stiffness and soreness.X-ray normal uka, abnormal patellar tilt and lateral subluxation.Impression: progressive patellar chondromalacia right knee".He was seen on (b)(6) 2016 complaining of right knee pain and an x-ray showed a "medial uka, mild djd lateral compartment, mild lateral patellar subluxation".On (b)(6) 2016 a bone scan report of the right knee notes a history of pain since (b)(6) 2014.The impression of this report was, "tibial spine region.Could be loosening".On (b)(6) 2016 a revision of the right uni-compartmental to a total knee arthroplasty was performed for a diagnosis of failed right unicondylar knee arthroplasty.X-ray printouts available for review include a series dated (b)(6) 2014, which is an ap and lateral of the right knee demonstrating a cemented medial unicondylar knee arthroplasty with skin staples in situ.Lateral subluxation of the tibia is noted.A series dated (b)(6) 2016, which is an ap of both knees, times two, an ap of the right, a lateral of the right, and a patellar view of both knees, demonstrating a right medial unicondylar knee arthroplasty with lateral subluxation of the tibia and a lateral tilt of the patella.X-rays dated (b)(6) 2016 are an ap and lateral of the right knee demonstrating a cemented total knee arthroplasty with a medial tibial augment.The clinician concluded that, "pain after uni-compartmental knee arthroplasty is commonly the result of progressive arthritis in one or both of the other two compartments of the knee.This is the likely situation in this case.The osteoarthritis of the other two compartments could have been accelerated by malposition of the uka components and lateral subluxation of the knee.There is no evidence any clinical symptoms are the result of factors of faulty component design, manufacturing or materials of the uni-compartmental knee arthroplasty components." conclusions: the clinician indicated that the osteoarthritis of the other two compartments could have been accelerated by malposition of the uka components and lateral subluxation of the knee.There is no evidence any clinical symptoms are the result of factors of faulty component design, manufacturing or materials of the uni-compartmental knee arthroplasty components.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Stryker pkr device failed.Patient has been in constant pain and have been sufferring since the day after surgery back in 2014.

• Brand Name: TRIATHLON PKR BASEPLATE #2 RM/LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5500049
• MDR Text Key: 40324322
• Report Number: 0002249697-2016-00812
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5620-B-202
• Device Lot Number: JXFNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other