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Adverse Event Report

CENTERPULSE ORTHOPEDICS, INC. POR STM TIB B/P RT SZ3 NK II KNEE PROSTHESIS   back to search results
Catalog Number 6212-01-230
Event Date 02/13/2003
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative

Method: a rep sample of explanted tibia baseplates have undergone pathological evaluation. Results: investigation into the failure continues. There is no assignable cause at this time.

 
Event Description

It was reported: pt was revised in 2003.

 
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Brand NamePOR STM TIB B/P RT SZ3 NK II
Type of DeviceKNEE PROSTHESIS
Baseline Brand NamePOR STM TIB B/P RT SZ3 NK II
Baseline Generic NameKNEE PROSTHESIS
Baseline Catalogue Number6212-01-230
Baseline Device FamilyNA
Baseline Device 510(K) NumberK936159
Baseline Device PMA NumberP940002
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/22/1995
Manufacturer (Section F)
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum drive
austin TX 78717
Manufacturer (Section D)
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum drive
austin TX 78717
Manufacturer Contact
ron yarbrough, supervisor
9900 spectrum dr
austin , TX 78717
(512) 432 -9437
Device Event Key438694
MDR Report Key449698
Event Key425846
Report Number2935620-2003-00047
Device Sequence Number1
Product CodeHSH
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 02/20/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number6212-01-230
Device LOT Number1445244
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/20/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2000
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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