MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5517F401

Device Problems Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Osteolysis (2377)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

"an event regarding observation of less dense bone on x-ray where the patient is asymptomatic involving a femoral component was reported.Through the investigation malposition of the femoral component was confirmed." method & results: -device evaluation and results: not performed as the components were not returned.-medical records received and evaluation: medical review indicates that: [.]"femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement,"[.]"this pi case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." -device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of the provided x-rays by a clinical consultant indicated"medical review indicates that: [.]"femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement,"[.]"this pi case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Remains implanted.

Event Description

Surgeon report "osteolysis"/bone appearance underneath the tibia plateau (the region underneath the plateau and about 1 cm) x-ray observation of less dense bone around the tibia prostheses during follow-up visits (3 m and 1 year) on (b)(6) 2016: as per investigation closure, medical consultant mentions the following, "less optimal position of femoral component in posterior direction, minor factor.This factor cannot be held responsible for the decrease in bmd.".

Manufacturer Narrative

An event regarding observation of less dense bone on x-ray where the patient is asymptomatic involving a femoral component was reported.Through the investigation malposition of the femoral component was confirmed." method & results: -device evaluation and results: not performed as the components were not returned.-medical records received and evaluation: medical review indicates that: "femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement." "this case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." -device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of the provided x-rays by a clinical consultant indicated"medical review indicates that: "femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement." "this case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Surgeon report "osteolysis"/bone appearance underneath the tibia plateau (the region underneath the plateau and about 1 cm).X-ray observation of less dense bone around the tibia prostheses during follow-up visits (3 m and 1 year).On 12/02/2016: as per investigation closure, medical consultant mentions the following, "less optimal position of femoral component in posterior direction, minor factor.This factor cannot be held responsible for the decrease in bmd.".

• Brand Name: TRIATHLON P/A CR BEADED #4L
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6214918
• MDR Text Key: 63608693
• Report Number: 0002249697-2016-04076
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 5517F401
• Device Lot Number: ADR8N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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): Required Intervention