• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5520-B-400
Device Problem Loss of Osseointegration (2408)
Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
Event Date 08/25/2021
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
 
Event Description
It was reported that the patient's right knee was revised.Patient presented in severe varus due to tibial baseplate loosening.Intra-operatively, it was noticed that the insert had cracked medially posteriorly.
 
Event Description
It was reported that the patient's right knee was revised.Patient presented in severe varus due to tibial baseplate loosening.Intra-operatively, it was noticed that the insert had cracked medially posteriorly.
 
Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted triathlon prim tib baseplate ¿ cemented with damage consistent with attempted implantation/explantation.A piece of the polyethylene insert appears to remain attached to the top of the baseplate.The photograph does not show any damage indicative of baseplate loosening.Material analysis: not performed as the device was not returned.Dimensional inspection: not performed as the device was not returned.Functional inspection: not performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: no other similar events were reported for the lot.Conclusion: visual inspection of the device photographs indicated damage to the device consistent with attempted implantation/explantation.The visual inspection did not confirm the reported loosening of the tibial baseplate.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 to indicate further evaluation is warranted, this record will be reopened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
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 Key12482519
MDR Text Key271738636
Report Number0002249697-2021-01564
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327050325
UDI-Public07613327050325
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 10/20/2021
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 Date10/24/2023
Device Model Number5520-B-400
Device Catalogue Number5520-B-400
Device Lot NumberDEX4OB
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/25/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received09/23/2021
Supplement Dates FDA Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-