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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5517F702
Device Problem Migration (4003)
Patient Problems Injury (2348); Joint Disorder (2373)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative

An event regarding subsidence/ subluxation involving a triathlon femoral component was reported. The event was confirmed via clinician review. Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: x-ray printouts include a series dated (b)(6) 2009, which is a pa and lateral of the right knee, demonstrating an uncemented total knee arthroplasty reduced in nominal position with no patellar resurfacing. Skin staples are in situ. X-rays dated (b)(6) 2019 are an ap, four laterals, and one patellar view of the right knee, which is essentially unchanged from the previous study, but the posterior subluxation of the femoral component is noted on the lateral x-rays. No clinical or past medical history, no examination of the explanted components, and no post-revision imaging studies are available for review. Based upon the information available for review, no determination can be made regarding the cause of the instability occurring ten years post-implantation and requiring revision of the tibial insert in this case. Product history review: not performed as the device lot details were not provided. Complaint history review: not performed as the device lot details were not provided. Conclusions: the clinician review revealed that the posterior subluxation of the femoral component is noted on the lateral x-rays dated (b)(6) 2019. The exact cause of the event could not be determined because insufficient information was provided. Further information such as device lot detail, clinical or past medical history, and post-revision imaging studies are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened. Device evaluated by manufacturer? not returned.

 
Event Description

Knee revision poly wear. Comment in adverse consequences details: patient needed knee revision due to instability. *update: based on medical review, x-rays dated (b)(6) 2019 are an ap, four laterals, and one patellar view of the right knee, which is essentially unchanged from the previous study, but the posterior subluxation of the femoral component is noted on the lateral x-rays.

 
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Brand NameTRIATHLON P/A CR BEADED #7R
Type of DevicePROSTHESIS, 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9530775
MDR Text Key185713966
Report Number0002249697-2019-04129
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
Report Date 12/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5517F702
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/30/2019 Patient Sequence Number: 1
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