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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM SZ2; C-STEM HIP IMPLANT : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US C-STEM SZ2; C-STEM HIP IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 961162000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event or Problem Description
Patient was revised due to address fracture of stem and pain.
 
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Brand Name
C-STEM SZ2
Common Device Name
C-STEM HIP IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8139831
Report Number1818910-2018-77441
Device Sequence Number1910035
Product Code KWA
UDI-Device Identifier10603295235194
UDI-Public10603295235194
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2015
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number961162000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/20/2018
Initial Report FDA Received Date12/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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