• 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 PS X3 TIBIAL INSERT IMPLANT

  • 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 PS X3 TIBIAL INSERT IMPLANT Back to Search Results
Catalog Number 5532-G-413
Device Problem Material Too Rigid or Stiff (1544)
Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032)
Event Date 06/01/2015
Event Type  Injury  
Event Description

Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint. Surgeon replaced patient's 13mm insert with an 11mm insert. All other components were well fixed with no issues.

 
Manufacturer Narrative

An event regarding stiffness leading to revision surgery involving a triathlon insert component was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as no product was returned for evaluation. -medical records received and evaluation: not performed as no medical records were received. -device history review: dhr review was satisfactory. -complaint history review: chr review confirmed that there were no other similar events reported for the lot. Conclusions: the reported event cannot be confirmed with the information provided. The exact cause of the event could not be determined with the limited information provided. Further information such as x-rays, operative reports, patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time. If the device or additional information becomes available, this investigation will be reopened.

 
Event Description

Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint. Surgeon replaced patient's 13mm insert with an 11mm insert. All other components were well fixed with no issues.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON PS X3 TIBIAL INSERT
Type of DeviceIMPLANT
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4863998
MDR Text Key6322652
Report Number0002249697-2015-02051
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 Other,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device Catalogue Number5532-G-413
Device LOT NumberMMP4XN
OTHER Device ID NumberSTERILE LOT: MSGMP31J4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2013
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: 06/23/2015 Patient Sequence Number: 1
-
-