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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS, INC. 1818910  SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157002100
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Tissue Damage (2104); Test Result (2695)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Ppf alleges metal wear, metallosis, and elevated metal ions.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
SUMMIT DUOFIX TAP SZ4 STD OFF
Common Device Name
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8270562
Report Number1818910-2019-81966
Device Sequence Number10797562
Product Code LPH
UDI-Device Identifier10603295059455
UDI-Public10603295059455
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K011489
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/03/2019
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 Expiration Date06/30/2022
Device Catalogue Number157002100
Device Lot Number249114
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/03/2019
Supplement Date Received by Manufacturer02/05/2019
Initial Report FDA Received Date01/23/2019
Supplement Report FDA Received Date02/05/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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