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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5536B400
Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Positioning Problem (3009)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 11/14/2017
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 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.
 
Event Description
It was reported that patient's right knee was revised due to loosening of the tibial component.Surgeon reported that he suspected the component was not fully seated.Rep has confirmed that it was the tibial baseplate component that was not fully seated.The reason for the poly revision was that a new insert was used with the new baseplate.
 
Manufacturer Narrative
An event regarding loosening of a tritanium baseplate component was reported.The event was confirmed through clinician review of the medical records.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: clinician review of the medical records provided indicated: complex component malposition with an oblique joint line and excessive posterior slope in combination with suboptimal initial implant-bone contact have contributed to an overload condition on the baseplate preventing adequate bone ingrowth fixation and requiring revision.The tritanium surface structure with bioinert properties may have played a modulating role.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: medical review of the records provided confirmed the reported loosening and concluded that complex component malposition with an oblique joint line and excessive posterior slope in combination with suboptimal initial implant-bone contact have contributed to an overload condition on the baseplate preventing adequate bone ingrowth fixation and requiring revision.The tritanium surface structure with bioinert properties may have played a modulating role.No further investigation for this event is possible at this time.
 
Event Description
It was reported that patient's right knee was revised due to loosening of the tibial component.Surgeon reported that he suspected the component was not fully seated.Rep has confirmed that it was the tibial baseplate component that was not fully seated.The reason for the poly revision was that a new insert was used with the new baseplate.
 
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Brand Name
TRITANIUM BPLATE TRIATHLON S4
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7104543
MDR Text Key94400995
Report Number0002249697-2017-03540
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327041491
UDI-Public07613327041491
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 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Catalogue Number5536B400
Device Lot NumberCTD16457
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/14/2017
Initial Date FDA Received12/11/2017
Supplement Dates Manufacturer Received01/11/2018
Supplement Dates FDA Received02/09/2018
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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