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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5536B600
Device Problems Device Slipped (1584); Insufficient Information (3190)
Patient Problems Edema (1820); Pain (1994); Swelling (2091); Injury (2348)
Event Date 09/20/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

The surgeon revised a triathlon tritanium baseplate and cs insert into a cemented baseplate and cs insert. The patient was exhibiting pain and swelling since implantation approximately a year ago and was believed it may have been due to loosening of the baseplate. When the surgeon revised it, the baseplate was well fixed but decided to revise anyway. This was the left knee of a bilateral patient.

 
Manufacturer Narrative

An event regarding size/fit issue involving a tritanium baseplate was reported. The event was confirmed through x rays. Method and results: device evaluation and results: not performed as product was not returned. Medical records received and evaluation: "the baseplate was somewhat undersized, at least one size, and providing a bigger supporting surface to the device, mechanical stability might have been a bit better shifting the balance towards improved bone ingrowth conditions. There may still have been areas with bone ingrowth resisting device removal while also fibrous tissue fixation may give the false impression of fixation because difficult to remove while still allowing more micromotion than normal between device and bone which may be responsible for synovitis with complaints of pain and swelling as reported. Given also the presence of visible gap spaces on x-ray between baseplate and bone, baseplate fixation has been limited or partial at best and as such still likely plays a role in the development of the patient¿s complaints. " device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there were no other events for the referenced lot. Conclusions: the medical review of the provided information confirms the problem. The clinician indicated that "the baseplate was somewhat undersized, at least one size, and providing a bigger supporting surface to the device, mechanical stability might have been a bit better shifting the balance towards improved bone ingrowth conditions. There may still have been areas with bone ingrowth resisting device removal while also fibrous tissue fixation may give the false impression of fixation because difficult to remove while still allowing more micromotion than normal between device and bone which may be responsible for synovitis with complaints of pain and swelling as reported. Given also the presence of visible gap spaces on x-ray between baseplate and bone, baseplate fixation has been limited or partial at best and as such still likely plays a role in the development of the patient¿s complaints. " no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened.

 
Event Description

The surgeon revised a triathlon tritanium baseplate and cs insert into a cemented baseplate and cs insert. The patient was exhibiting pain and swelling since implantation approximately a year ago and was believed it may have been due to loosening of the baseplate. When the surgeon revised it, the baseplate was well fixed but decided to revise anyway. This was the left knee of a bilateral patient.

 
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Brand NameTRITANIUM BPLATE TRIATHLON S6
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6041534
MDR Text Key57873602
Report Number0002249697-2016-03267
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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 09/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number5536B600
Device LOT NumberCTD6814
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 Received11/17/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2015
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: 10/19/2016 Patient Sequence Number: 1
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