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 TRIATHLON PKR BASEPLATE #2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  • 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 PKR BASEPLATE #2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 5620-B-201
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 11/15/2018
Event Type  Injury  
Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated.
 
Event Description
Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene was damaged 4 more polyethylenes failed to seat.Update 20/november/2018: spoke to rep.Total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
 
Manufacturer Narrative
An event regarding seating/locking issues involving a triathlon pkr baseplate was reported.The event was not confirmed.Product evaluation and results: review of the device by a material analysis engineer that, ¿damage observed on baseplate consistent with implantation and explantation processes and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ clinician review: not performed as this was an intraoperative event.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.The event could not be confirmed as the implant was returned damaged and a functional or dimensional inspection could not be conducted.Examination of the device by the material analysis engineer indicated that damage observed is consistent with implantation process.No further investigation for this event is required at this time.If the additional information is received, this investigation will be reopened and re-evaluated.
 
Event Description
Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene was damaged 4 more polyethylenes failed to seat.Update 20/november/2018: spoke to rep.Total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
 
Manufacturer Narrative
Correction to pma/510k reportability awareness date.
 
Event Description
Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene was damaged 4 more polyethylenes failed to seat.Update (b)(6) 2018: spoke to rep.Total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIATHLON PKR BASEPLATE #2 LM/RL
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8160708
MDR Text Key130222770
Report Number0002249697-2018-04045
Device Sequence Number1
Product Code HRY
UDI-Device Identifier07613327015508
UDI-Public07613327015508
Combination Product (y/n)N
PMA/PMN Number
K082567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 02/06/2019
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? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number5620-B-201
Device Lot NumberA7U7XA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Initial Date Manufacturer Received 11/15/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received07/08/2019
01/08/2019
Supplement Dates FDA Received02/05/2019
02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
-
-