• 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 IMPACTION HANDLE 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 IMPACTION HANDLE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-4-810
Device Problems Degraded (1153); Material Disintegration (1177); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Degradation of the handle was noticed before use in the operation. The handle was sticky and changed color.

 
Manufacturer Narrative

An event regarding handle damage of a triathlon impaction handle was reported. Conclusion: visual inspection confirmed the reported event; the handle of the device is discolored and degraded. The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event. This event meets the definition of preventive maintenance; no further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Degradation of the handle was noticed before use in the operation. The handle was sticky and changed color.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIMPACTION HANDLE
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5209640
MDR Text Key31010794
Report Number0002249697-2015-03681
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-4-810
Device LOT NumberN3H24
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/08/2015 Patient Sequence Number: 1
-
-