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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5526B600
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 10/24/2019
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
 
Event Description
An uncemented triathlon baseplate was revised due to loosening.Swabs were taken during the procedure, with the results coming back ( over the phone) as no infection.Surgeon at the end of the case notes there was very little bony in growth on the tibia, though the femur was well fixed.He also noted a grey coloration of the tissues where the baseplate was not well fixed.
 
Manufacturer Narrative
An event regarding revision due to loosening involving a triathlon baseplate was reported.The event was confirmed based on the clinician review.Method & results: device evaluation and results: visual inspection: visual inspection was performed on the returned device.It noted some minor scratches to the surface consistent with explant damage.Nothing else of note was seen.Dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material evaluation was completed and indicated the following comments: ma: material analysis is not performed as loosening is not related to material integrity issue.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: rejected for medical review: x-ray images provided confirm tibial loosening, need additional information; primary and revision operative reports, clinical and past medical history and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
 
Event Description
An uncemented triathlon baseplate was revised due to loosening.Swabs were taken during the procedure, with the results coming back ( over the phone) as no infection.Surgeon at the end of the case notes there was very little bony in growth on the tibia, though the femur was well fixed.He also noted a grey coloration of the tissues where the baseplate was not well fixed.
 
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Brand Name
TRIATHLON PRIM BEAD PA SZE6 BP
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9353319
MDR Text Key167325696
Report Number0002249697-2019-03839
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327041361
UDI-Public07613327041361
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number5526B600
Device Lot NumberCH49R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
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