MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM TRL S/S #4RT; KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5510T402

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

During a right press-fit total knee procedure.While trialing the femoral component surgeon noticed that there was a slight rocking motion and gap originating around the distal, and anterior chamfer cuts.The mis 4 in1 cutting block was placed back onto the femur to confirm cuts were made properly.The femoral trial then was reintroduced onto the femur with less gap, and rocking but a 1 to 2mm gap around anterior chamfer.The surgeon felt like the fit was adequate and choose to stay with press fit.Upon impacting the femoral component there was no noticeable gap.

Manufacturer Narrative

Expiration date changed to blank as device does not have an expiration date; manufacturing site for devices; type of reportable event, device evaluated by mfg, labeled for single use, usage of device.An event regarding a size/fit issue during trialing involving a triathlon trial component was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the device was returned in used condition.There are scratches and discoloration throughout.Dimensional inspection: the device is dimensionally within specification.Medical records received and evaluation: one part of the accuracy of bone preparation is controlled by the cutting block, the other by the type of saw plus the handling by the surgeon.Of these is usually the saw a most critical part.Thin saw blades may deflect by dense bone in a cutting space that may have space between saw blade and guiding slot of the cutting block.This is the most frequent cause for deviation of the saw blade during preparation and thus imperfect fit between at first trial and then final implant to bone.To remedy this, the precision saw system has been designed to improve on this.The type of saw was not provided in this case.Other sources for bone plane deviation may be suboptimal fixation of the cutting block on the bone.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.Conclusions: the device was manufactured in 2004.It is unknown how many times the device has been used in surgery.The trial component was returned in used condition.There are scratches and discoloration throughout and the device is dimensionally within specification.As stated by the clinician "one part of the accuracy of bone preparation is controlled by the cutting block, the other by the type of saw plus the handling by the surgeon.Of these is usually the saw a most critical part.Thin saw blades may deflect by dense bone in a cutting space that may have space between saw blade and guiding slot of the cutting block.This is the most frequent cause for deviation of the saw blade during preparation and thus imperfect fit between at first trial and then final implant to bone.To remedy this, the precision saw system has been designed to improve on this.The type of saw was not provided in this case.Other sources for bone plane deviation may be suboptimal fixation of the cutting block on the bone.As such are there many possibilities as potential cause for the problem about which there is no specific info available for this patient, all remains an educated guess at potential causes of the problem although it would not be possible to provide an exact failure cause due to limited information.We may suspect procedure-related factors but the level of evidence is too thin to make a clear statement about this due to lack of info." 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

During a right press-fit total knee procedure.While trialing the femoral component surgeon noticed that there was a slight rocking motion and gap originating around the distal, and anterior chamfer cuts.The mis 4 in1 cutting block was placed back onto the femur to confirm cuts were made properly.The femoral trial then was reintroduced onto the femur with less gap, and rocking but a 1 to 2mm gap around anterior chamfer.The surgeon felt like the fit was adequate and choose to stay with press fit.Upon impacting the femoral component there was no noticeable gap.

• Brand Name: TRIATHLON CR FEM TRL S/S #4RT
• Type of Device: KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7153134
• MDR Text Key: 96002733
• Report Number: 0002249697-2017-03764
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172326
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2009
• Device Catalogue Number: 5510T402
• Device Lot Number: J71465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 137