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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ9 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ9 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-02-165
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 05/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised due to infection.Doi: (b)(6) 2021, dor: (b)(6) 2021, affected side: right hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
SUMMIT DUOFIX TAP SZ9 STD OFF
Common Device Name
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11843439
Report Number1818910-2021-10589
Device Sequence Number14578715
Product Code LPH
UDI-Device Identifier10603295059509
UDI-Public10603295059509
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K011489
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/05/2021
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 Model Number1570-02-165
Device Catalogue Number157002165
Device Lot NumberH82304
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/05/2021
Supplement Date Received by Manufacturer06/15/2021
Initial Report FDA Received Date05/18/2021
Supplement Report FDA Received Date06/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 54X28 BLU; SUMMIT DUOFIX TAP SZ9 STD OFF; ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 54X28 BLU; SUMMIT DUOFIX TAP SZ9 STD OFF
Outcome Attributed to Adverse Event Required Intervention;
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