Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 TRI TS BASEPLATE SIZE 4; 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 TRI TS BASEPLATE SIZE 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5521-B-400
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 08/10/2023
Event Type  Injury  
Event Description
It was reported that the patient's right knee was revised due to lateral subsidence of the tibia after the patient had an 'accident' (nature of the accident not reported to the rep).The baseplate and ps insert were revised to a baseplate with stem, augments and cone with a ts insert (rep confirmed the surgeon wanted additional stability for the patient's construct, there were no allegations against the revised insert).Rep confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
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.H3 other text : not available.
 
Manufacturer Narrative
An event regarding subsidence involving a triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient's knee was revised due to subsidence of the tibial baseplate.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that the patient's right knee was revised due to lateral subsidence of the tibia after the patient had an 'accident' (nature of the accident not reported to the rep).The baseplate and ps insert were revised to a baseplate with stem, augments and cone with a ts insert (rep confirmed the surgeon wanted additional stability for the patient's construct, there were no allegations against the revised insert).Rep confirmed that no further information will be released by the hospital or surgeon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRI TS BASEPLATE SIZE 4
Type of Device
PROSTHESIS, 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
joann ripoli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17648838
MDR Text Key322241314
Report Number0002249697-2023-00968
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327026061
UDI-Public07613327026061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5521-B-400
Device Lot NumberODU3XA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age75 YR
Patient SexFemale
-
-