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Adverse Event Report

CENTERPULSE ORTHOPEDICS, INC. PROT POR SHL W/SEALABLE SCWHLS SZ55MM HIP PROSTHESIS   back to search results
Catalog Number 4363-00-055
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Event Description

Patient has been revised.

 
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Brand NamePROT POR SHL W/SEALABLE SCWHLS SZ55MM
Type of DeviceHIP PROSTHESIS
Baseline Brand NamePROT POR SHL W/SEALABLE SCWHLS SZ55MM
Baseline Generic NameKNEE PROSTHESIS
Baseline Catalogue Number4363-00-055
Baseline Device FamilyNA
Baseline Device 510(K) NumberK970706
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/22/1997
Manufacturer (Section F)
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum dr.
austin TX 78717
Manufacturer (Section D)
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum dr.
austin TX 78717
Manufacturer Contact
jim gonzales, supervisor
9900 spectrum drive
austin , TX 78717
(512) 432 -9688
Device Event Key452561
MDR Report Key463619
Event Key439295
Report Number2935620-2003-00117
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Remedial Action Replace
Type of Report Initial
Report Date 05/14/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4363-00-055
Device LOT Number1391587
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/16/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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