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

Catalog Number 5551-G-381

Device Problems Degraded (1153); Osseointegration Problem (3003)

Patient Problems Loss of Range of Motion (2032); Injury (2348); Inadequate Osseointegration (2646)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding range of motion issues and damage and loosening involving a triathlon patella was reported.The event of range of motion was not confirmed.The event of damage of the insert was confirmed by the inspection of returned device.The event of loosening was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 04/22/2019 which indicated that the articulating and distal surfaces of the patella insert.Damage consistent with contact against the femoral component was observed on the insert.Damage consistent with the explanation process was observed on the insert.A detailed image of the articulating surface of the insert, with burnishing, scratching and third-body indentations being observed.These are common damage modes of uhmwpe.A material analysis has been performed.The report concluded that burnishing, scratching and third-body indentations were observed on the post and condyles of the triathlon insert in addition to the articulating surface of the patella insert.These are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "on (b)(6) 2013 a "left total knee arthroplasty with computer guidance" was performed for a pre- and post-operative diagnosis of "end-stage arthritis with left knee with varus deformity".The operative report describes spinal anesthesia and a tourniquet time of eighty minutes.The pre-operative diagnosis notes "fixed contracture posteriorly and gait abnormality".The operative report notes, ".7 0 to 100 varus correctable.Used computer guided 3-dimensional jig to put on the distal femur.Sized the tibia to 7.Complications: clicking requiring bony removal along with equipment malfunction of my gown, the battery went dead necessitating repeat cementation".An office visit note for (b)(6) 2013 states, "doing very well.X-ray excellent alignment.Return four weeks." when he returned on (b)(6) 2013 it was noted, called last week concerns about wound.Placed him on keflex.Otherwise doing well.Pleased with his prop-ess.No erythema and no drainage.Active range of motion 00 to 1200 on (b)(6) 2013 the office visit note states, " feeling good.Incision well-healed 00 to 1300 gait normal." on (b)(6) 2013 the officer visit note states, ".Knee feeling extremely well with no problems.Return for one-year post-op x-ray." he was next seen on (b)(6) 2014 at which time it was noted, ".Doing very well.No pain.X-ray excellent alignment possibly some osteolysis beneath tibial component.".On (b)(6) 2018 the note states, "complains of increased swelling left knee.0 0 to 1400.No joint line tenderness x-ray osteolysis proximal tibial region, lateral yeater then medial.Consistent with aseptic loosening or osteolysis or occult infection.Osteoarthritis right knee cbc, sed rate, crp ordered." on (b)(6) 2018 it was noted, ".Infection labs negative aspirated 60ml synovial fluid, sent to lab.Ordered bone scan.On (b)(6) 2018 a bone scan of the left knee report states, ".Increased uptake.Most intense.Tibial component.Most consistent with loosening infection may have similar appearance.".His (b)(6) 2018 office visit note states, ".Runs three times a week having pain with this.And had to stop.Assessment.Loosening left knee prosthesis.Primary osteoarthritis right knee.Plan revision left tka.Right tka at a later date.".On (b)(6) 2018 a "revision left total knee arthroplasty, repair medial collateral ligament, and synovial biopsy was performed "for a diagnosis of "failed left tka".The operative report describes spinal anesthesia and a tourniquet time of 103 minutes.The operative report notes, " significant amount of fluid.Chronically inflamed looking tissue with hypertrophic synovium.Suspicion this was severe case of aseptic loosening.Took photos.Biopsy sent to pathology femur had some areas that had bonded with the cement.Tibia grossly loose removed by hand femur and patella removed without significant bone loss removed excess cement.Recut tibia.".A surgical pathology report dated (b)(6) 2018 notes, "specimen a, left knee synovium, negative for acute inflammation.Specimen b, left knee tissue, negative for acute inflammation." knee hardware was returned with gross description only.On (b)(6) 2018 an office visit note states, "had aseptic loosening secondary to polyethylene wear generally doing well."x-rays dated (b)(6) 2013 is an ap and lateral of the left knee demonstrating a cemented posterior stabilized total knee arthroplasty.The x-rays are labeled "portable" and skin staples are in situ.The tibial component appears to be sloped anteriorly a few degrees with a slight medial translocation.The knee is reduced and the components appears well fixed.X-rays dated (b)(6) 2018 are an ap and lateral and patellar view of the left knee, which are unchanged from the previous description with some stress shielding/osteolysis noted under the medial and lateral tibial plateaus.The keel of the tibial component appears well fixed.X-rays dated (b)(6) 2018 is an ap and lateral of the left knee demonstrating a long-stem revision left total knee arthroplasty with the patient in a brace.There is no confirmation of the (b)(6) 2018 office visit statement "aseptic loosening secondary to polyethylene wear" either by examination of the explanted insert or surgical pathology report consistent with polyethylene debris.There is no confirmation of loosening of the patella or femoral component.The initial position of the tibial component with slight anterior slope, as well as the necessity to recement the components at the primary surgery, may have exposed the posterior stabilized tibial component to impingement and compromised cement fixation.The tibial post could have resulted in the clicking sensation and possible mechanical loosening, which subsequently was described.This was confirmed by the material analysis report.There is no evidence this clinical event was related to factors of component design, manufacturing or materials.Device history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: it was reported that the patient was experiencing range of motion issues and was revised.A material analysis has been performed.The report concluded that burnishing, scratching and third-body indentations were observed on the post and condyles of the triathlon insert in addition to the articulating surface of the patella insert.These are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The available medical records were provided to the consulting clinician for a review which noted that there is no confirmation of the (b)(6) 2018 office visit statement "aseptic loosening secondary to polyethylene wear" either by examination of the explanted insert or surgical pathology report consistent with polyethylene debris.There is no confirmation of loosening of the patella or femoral component.The initial position of the tibial component with slight anterior slope, as well as the necessity to recement the components at the primary surgery, may have exposed the posterior stabilized tibial component to impingement and compromised cement fixation.The tibial post could have resulted in the clicking sensation and possible mechanical loosening, which subsequently was described.This was confirmed by the material analysis report.There is no evidence this clinical event was related to factors of component design, manufacturing or materials.The event of damage was confirmed.The event of range of motion was not confirmed.The event of loosening of femoral component was not confirmed.As per product remediation tracker, the device is not subject to a recall.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient's wife called reporting patient had left knee replacement surgery (b)(6) 2013.Patient began experiencing range of motion issues and was revised on (b)(6) 2018.Patient's wife reports that revising surgeon showed her and her husband pictures of the explanted device, and explained that "the plastic was bubbled" and that the surgeon reported that the device was removed with virtually no resistance or effort, and that the device had severed the patient's medial lateral collateral ligament.Surgeon reported to patient the device would be given to the stryker sales rep for return to stryker.Spoke to sales rep.Rep reported that hospital's policy will not allow the release of explanted devices, and that he has no recollection of having received a device from the surgeon for return.Patient is inquiring as to whether the revised device(s) is/are subject to any recall, and is inquiring about compensation.Patient does not have implant information at the time of report.Update as per medical review".Suspicion this was severe case of aseptic loosening¿femur had some areas that had bonded with the cement.Tibia grossly loose.Removed by hand¿ femur and patella removed without significant bone loss.".

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8887632
• MDR Text Key: 154685428
• Report Number: 0002249697-2019-02807
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014822
• UDI-Public: 07613327014822
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

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: 01/31/2018
• Device Catalogue Number: 5551-G-381
• Device Lot Number: 9L19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 81