• 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 NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM 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 NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5537-G-316
Device Problem Mechanical Problem (1384)
Patient Problems Pain (1994); Injury (2348)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: tri ts femur sz4 right; 5512-f-402; swzp; tri ts baseplate size 3; 5521-b-300; mzbod; dura duration all poly pat xsm; 6642-2-040; 00515424; triathlon femoral distal augment 5mm - size 4 right; 5540-a-402; tbpw; tri press-fit stem 12mm x 100mm; 5565-s-012; m9a3j; tri press-fit stem 17mm x 100mm; 5565-s-017; 0034135a; triathlon sym cone aug sz b; 5549-a-120; a604. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not available.

 
Event Description

This pi is for the poly swap with i&d on (b)(6) 2020: procedure: the patient had difficulties with the right knee due to mechanical failure. Patient underwent a revision of the right total knee replacement (b)(6) 2013. Patient underwent right knee revision to treat the pain all components exchanged in (b)(6) 2015 reported as cors per 1473knee. Patient underwent right total knee replacement with revision of poly insert and incision and drainage and synovectomy for right infected total knee replacement (b)(6) 2020.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10459229
MDR Text Key204534519
Report Number0002249697-2020-01749
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2019
Device MODEL Number5537-G-316
Device Catalogue Number5537-G-316
Device LOT NumberMNNT3N
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2014
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: 08/27/2020 Patient Sequence Number: 1
-
-