• 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
Catalog Number 5520-B-300
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Injury (2348)
Event Date 04/10/2012
Event Type  Injury  
Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies. There have been no other similar events for the lot referenced. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to: "history of left total knee arthroplasty 18 months ago. Chronic pain about the proximal left tibia with concern for aseptic loosening of the tibial component. Grossly loose tibial component. Proc revision lt total knee, tibial component only".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8504159
MDR Text Key141605235
Report Number0002249697-2019-01582
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 04/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device Catalogue Number5520-B-300
Device LOT NumberBJJH
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 Received03/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2010
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: 04/11/2019 Patient Sequence Number: 1
-
-