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 INSERT X3 #3 LM/RL -8MM; 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 INSERT X3 #3 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 5630-G-308
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.
 
Event Description
Primary procedure, manual left medial pkr.It was reported that the poly would not go in correctly to the baseplate using the tibial impactor (catalog 5650-4-812).Another device of the same catalog but different lot was obtained and performed correctly.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was being used.
 
Manufacturer Narrative
An event regarding seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Method & results: - product evaluation and results: visual inspection of the returned device noted that dent marks and damages are observed on the surface of the device.Examination of the returned device by a material analysis engineer noted that implantation/explantation damage was observed on the rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.Dimensional and functional analysis were not performed as the device was returned in damaged condition.- clinician review: no medical records were received for review with a clinical consultant.- device history review: all 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 reported lot.Conclusion: it was reported that the poly would not go in correctly to the baseplate using the tibial impactor.Visual inspection of the returned device noted that dent marks and damages are observed on the surface of the device.Examination of the returned device by a material analysis engineer noted that implantation/explantation damage was observed on the rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.The event was not confirmed and the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Primary procedure, manual left medial pkr.It was reported that the poly would not go in correctly to the baseplate using the tibial impactor (catalog 5650-4-812).Another device of the same catalog but different lot was obtained and performed correctly.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was being used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIATHLON PKR INSERT X3 #3 LM/RL -8MM
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 Key8703425
MDR Text Key148165465
Report Number0002249697-2019-02264
Device Sequence Number1
Product Code HRY
UDI-Device Identifier07613327015928
UDI-Public07613327015928
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
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue Number5630-G-308
Device Lot NumberDD0D41
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Date Manufacturer Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
-
-