MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #1; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5520B100

Device Problems Mechanical Problem (1384); Osseointegration Problem (3003)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)

Event Date 05/30/2017

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 no similar events for the reported lot.Additional information has been requested and if received will be provided in a supplemental report.

Event Description

Dr.(b)(6) revised a triathlon patient originally done (b)(6) 2015.He replaced the femur and tibial components but kept the patella.This was due to patient not getting full flexion and he felt the tibial baseplate may have been loose.

Manufacturer Narrative

An event regarding revision due to loosening involving a triathlon baseplate was reported.The event was confirmed through medical review.Device evaluation and results: not 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 indicated: revision of triathlon cr femur and tibia due to limited flexion and possible baseplate loosening some 2-years post primary arthroplasty in a female patient of (b)(6) years ((b)(6)) with unknown weight and activity level.X-rays confirm implantation of triathlon cr components with the patella also resurfaced and tracking well.Adequate size and position of components with good alignment of knee.The baseplate has correct tibial slope and posterior femoral condylar offset.The femoral component has stable cemented fixation but the tibial baseplate has radiolucent lines visible below the baseplate and behind the keel.There is no cement visible anterior and medial/lateral of the keel, only somewhat behind the keel.No implants were returned for investigation and no other clinical information is available.Causes for poor rom are multi-factorial but can grossly be categorised into patient related factors and surgery related factors.Usually, the worse the preoperative rom, the worse the postoperative rom due to muscle atrophy, contracture or other scarring and/or osteophyte formation by oa.Every new surgical procedures adds more scar tissue to the already present, so many previous surgeries may lead in general to worse functional outcome regarding rom.The second aspect of the case involves suspected baseplate loosening.This was already suspected by the surgeon and is also evident from the x-rays.There are radiolucent lines visible between cement and device below the baseplate while also behind the keel where hardly any cement is visible around the keel section, only some cement is present behind the keel.Because cementation is part of the surgical technique under responsibility of the surgeon also this second aspect of tibial loosening is a procedure-related matter.No evidence is present to suspect device-related factors although no implants were returned for investigation to confirm such.Nevertheless the provided failure scenario is plausible enough to accept as principal failure mode without additional factors being required.Failure mode of this case is thus procedure-related regarding bone cement technique while the arthrofibrosis aspect is also procedure-related with sometimes additional patient-related issues about which this case has no info.As such is this case not device-related.Procedure-related factors: - arthrofibrosis due to scar tissue formation after.Arthroplasty surgery - suboptimal baseplate cementation technique.Patient-related factors - no info.Device-related factors: - none.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the medical review indicates that arthrofibrosis due to scar tissue formation after arthroplasty surgery has caused limited in knee flexion while suboptimal baseplate cementation has contributed to premature fixation failure of the baseplate requiring revision after 2-years.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded that loosening may result from other factors not necessarily related to the device.

Event Description

Dr.(b)(6) revised a triathlon patient originally done (b)(6) 2015.He replaced the femur and tibial components but kept the patella.This was due to patient not getting full flexion and he felt the tibial baseplate may have been loose.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #1
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6667309
• MDR Text Key: 78398243
• Report Number: 0002249697-2017-02006
• Device Sequence Number: 1
• Product Code: MBH
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: 5520B100
• Device Lot Number: EKSES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• 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; Required Intervention
• Patient Age: 60 YR