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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ADJUSTMENT BLOCK - STANDARD KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH ADJUSTMENT BLOCK - STANDARD KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 6541-1-600
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation. A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there were no similar events for the reported lot.

 
Event Description

During dr. (b)(6) tka case, the scrub tech noticed the 6541-1-600 lot p1v03 adjustment block was getting jammed or releasing unexpectedly.

 
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Brand NameADJUSTMENT BLOCK - STANDARD
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6692008
MDR Text Key79243112
Report Number0002249697-2017-02124
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-600
Device LOT NumberP1V03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/03/2007
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: 07/06/2017 Patient Sequence Number: 1
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