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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problem Collapse (1099)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 02/16/2015
Event Type  Injury  
Event Description

Patient had triathlon cr knee replacement done on right knee in (b)(6) 2014. Patient fell in (b)(6) 2014 sustaining a tibial plateau fracture of his right knee. No surgical intervention to repair fracture, only wearing brace was prescribed. Patient still had pain and x-ray revealed collapse under tibial component. Revision surgery scheduled using triathlon ts system.

 
Manufacturer Narrative

Catalogue number unknown at this time. Device description reported as an unknown size 7 triathlon tibial tray. An evaluation of the device cannot be performed as the device and additional information were not made available to the manufacturer due to hospital policy. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
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Brand NameUNKNOWN_RECONSTRUCTIVE_PRODUCT
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4592692
MDR Text Key5447223
Report Number0002249697-2015-00695
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_REC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/11/2015 Patient Sequence Number: 1
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