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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, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520-B-300
Device Problems Failure to Osseointegrate (1863); Malposition of Device (2616); Insufficient Information (3190)
Patient Problems Rheumatoid Arthritis (1724); Pain (1994); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/16/2015
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. Not returned to the manufacturer.

 
Event Description

Patient had a knee revison on her left leg on (b)(6) 2015 after experiencing pain and loss of mobility for approximately 11 months. Patient had a bone scan done with revealed that the component was loose. Original implant date was (b)(6) 2014.

 
Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon baseplate was reported. The event was confirmed. Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "the primary harm involved is aseptic loosening of the tibial component of a primary tka in a patient with rheumatoid arthritis and osteopenia. The component itself appeared to be implanted in a sub optimal varus position. The combination of poor bone stock and mechanical overload contributed to early loosening of this component. There is no evidence for any defect in the implant or its manufacture. " device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced. Conclusions: the reported event was confirmed as per provided medical records that were reviewed by consulting clinician who indicated that primary harm involved is aseptic loosening of the tibial component in a patient with rheumatoid arthritis and osteopenia. The component itself appeared to be implanted in a sub optimal varus position. The root cause of the primary harm determined is the combination of poor bone stock and mechanical overload which resulted in early loosening of the component. There is no evidence for any defect in the implant or its manufacture. A capa trend analysis was conducted for the reported failure mode and concluded that loosening may result from other factors not necessarily related to the device. If additional information and/or device becomes available, this investigation will be reopened. Product surveillance will continue to monitor for trends.

 
Event Description

Patient had a knee revison on her left leg on (b)(6) 2015 after experiencing pain and loss of mobility for approximately 11 months. Patient had a bone scan done with revealed that the component was loose. Original implant date was (b)(6) 2014.

 
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Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5631967
MDR Text Key44414892
Report Number0002249697-2016-01519
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device Catalogue Number5520-B-300
Device LOT NumberKGKID
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/29/2014
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: 05/04/2016 Patient Sequence Number: 1
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