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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON STEM EXTENDER 25MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON STEM EXTENDER 25MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5571-S-025
Device Problems Corroded (1131); Material Deformation (2976)
Patient Problems Cyst(s) (1800); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)
Event Date 05/14/2012
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Letter received from patient's lawyers advising the stryker ts triathlon knee replacement is "defective and materially contributed to. On going left lower limb problems including the development of a pseudo-tumour". Patient is reports left knee problems following surgery on the (b)(6) 2012. Please see communication log for details regarding additional information. As per op report: comments. Triathlon ts cemented revision knee from an (b)(6) year old male revised after 4 years due to osteolysis and alval (pseudotumour) is presented for analysis. High activity level and medial bone loss around the tibial component are considered contributory factor to failure of the device. Femoral component: a combination of bone and fibrous tissue onto cement mantle indicating a well fixed components - numerous longitudinal scratches on bearing surface threaded boss covered with organic material and showing wear on the surface in contact with stem extender (fig. 1). Femoral stem extender: corrosion and wear in the base of threaded trunnion from uneven engagement with femoral component boss covered with organic material (fig. 2). Femoral stem: wear in the base of threaded trunnion from uneven engagement with femoral extender tibia baseplate: polished cement surface, indicative of micromotion, postero-medially bone tissue still attached to the cement mantle, anteriorly severe fretting corrosion of the surface of the boss as well as corrosion deposits in the threaded boss in contact with stem trunnion. Tibial stem: component was loose and removed from the baseplate manually gross fretting and corrosion in the trunnion: stem surface (inset, fig. 4), and in the trunnion threads (fig. 5) polyethylene (pe) insert: slight wear on the bearing surface, mostly scratching and burnishing around the ps post, posteriorly and media-lateral regions from contact with the femoral component.

 
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Brand NameTRIATHLON STEM EXTENDER 25MM
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8229580
MDR Text Key132484011
Report Number0002249697-2019-00118
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5571-S-025
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2018
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: 01/08/2019 Patient Sequence Number: 1
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