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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5520-B-300
Device Problems Material Discolored (1170); Malposition of Device (2616); Delamination (2904); Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
Patient Problems Fall (1848); Damage to Ligament(s) (1952); Injury (2348)
Event Date 03/28/2017
Event Type  Injury  
Manufacturer Narrative

Reported event: an event regarding malposition involving a triathlon baseplate was reported. The event was confirmed through medical records method and results: -device evaluation and results: visual inspection was performed as part of the mar on the 12-june-2017 which concluded that the insert exhibited delamination, scratching, burnishing, and third-body indentations. These are common damage modes of uhmwpe. Damage was observed on the articulating surface of the femoral component and on the posterior end of the base plate, consistent with contact against each other. No materials or manufacturing defects were observed on the surfaces examined. -medical records received and evaluation: the tibial baseplate has an excessive posterior tibial slope with radiolucent lines below the baseplate. Hardly any bone cement around the keel section of the baseplate. The baseplate is in subluxation position with the femoral component riding over the posterior rim of the tibial bearing. In 2017, femoral subluxation developed requiring revision to triathlon ts components. X-rays confirm implantation of triathlon cr components with the patella not resurfaced. There is adequate size and position of the femoral component with stable cemented fixation. The tibial baseplate has an excessive posterior tibial slope of 16° with radiolucent lines visible below the baseplate. Revision surgery was undertaken by exchange to ts devices with additional distal augment on the femoral side and a tibial stem extender below the baseplate as listed in the revision surgery report. No post revision x-rays are available. No device-related factors are evident from the material as also confirmed by the mar findings, while the failure mechanism is fully explained by procedure-related factors concerning the type and positioning of the devices which is under the full responsibility of the surgeon and the reported bike accident as patient-related factor. This pi case is not device-related but caused by an adverse mix of procedure-related and patient- related factors. Procedure-related factors: - baseplate malposition in excessive posterior tibial slope. - suboptimal baseplate cementation. Patient-related factors - bike accident with knee trauma. Device-related factors: - none. Diagnosis:- baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017. -device history review: indicate all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there were no other similar reported events for the lot referenced. Conclusions: review of the medical records provided indicated that baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017. 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

The patient had an initial surgery in 2009. The patient was involved in a bike accident in 2015, and contacted the clinic. Instability was confirmed but the patient did not want to have a revision surgery until now. Baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017.

 
Manufacturer Narrative

An event regarding malposition involving a triathlon baseplate was reported. The event was confirmed through medical records. Method & results: device evaluation and results: visual inspection was performed as part of the mar on the 12-june-17 which concluded that the insert exhibited delamination, scratching, burnishing, and third-body indentations. These are common damage modes of uhmwpe. Damage was observed on the articulating surface of the femoral component and on the posterior end of the base plate, consistent with contact against each other. No materials or manufacturing defects were observed on the surfaces examined. Medical records received and evaluation: the tibial baseplate has an excessive posterior tibial slope with radiolucent lines below the baseplate. Hardly any bone cement around the keel section of the baseplate. The baseplate is in subluxation position with the femoral component riding over the posterior rim of the tibial bearing. In 2017, femoral subluxation developed requiring revision to triathlon ts components. X-rays confirm implantation of triathlon cr components with the patella not resurfaced. There is adequate size and position of the femoral component with stable cemented fixation. The tibial baseplate has an excessive posterior tibial slope of 16° with radiolucent lines visible below the baseplate. Revision surgery was undertaken by exchange to ts devices with additional distal augment on the femoral side and a tibial stem extender below the baseplate as listed in the revision surgery report. No post revision x-rays are available. No device-related factors are evident from the material as also confirmed by the mar findings, while the failure mechanism is fully explained by procedure-related factors concerning the type and positioning of the devices which is under the full responsibility of the surgeon and the reported bike accident as patient-related factor. This case is not device-related but caused by an adverse mix of procedure-related and patient- related factors. Procedure-related factors: baseplate malposition in excessive posterior tibial slope. - suboptimal baseplate cementation. Patient-related factors: bike accident with knee trauma. Device-related factors: none. Diagnosis: baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017. Device history review: indicate all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there were no other similar reported events for the lot referenced. Conclusions: review of the medical records provided indicated that baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017. 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

The patient had an initial surgery in 2009. The patient was involved in a bike accident in 2015, and contacted the clinic. Instability was confirmed but the patient did not want to have a revision surgery until now. Baseplate malposition in excessive posterior tibial slope may have caused pcl damage that made the knee at risk for complete pcl rupture during the trauma of 2015. Progressive instability over time with ultimately knee subluxation required revision in 2017.

 
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Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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 Key6744700
MDR Text Key81069730
Report Number0002249697-2017-02289
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/03/2014
Device Catalogue Number5520-B-300
Device LOT NumberSM7RY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/03/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/26/2017 Patient Sequence Number: 1
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