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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-02-120
Medical Device Problem Codes Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 10/08/2020
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
Revision of depuy synthes products.Summit stem and head was removed as the stem was loose and had subsided.Not due to infection.Duraloc cup with two screws and liner were removed.New acetabular components were implanted.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).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 manufacturing or material 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 SZ6 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 Key10719263
Report Number1818910-2020-23082
Device Sequence Number1139771
Product Code LPH
UDI-Device Identifier10603295059479
UDI-Public10603295059479
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K011489
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/08/2020
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? Yes
Operator of Device Health Professional
Device Model Number1570-02-120
Device Catalogue Number157002120
Device Lot NumberBR7C41000
Initial Date Received by Manufacturer 10/08/2020
Supplement Date Received by Manufacturer12/15/2020
Initial Report FDA Received Date10/22/2020
Supplement Report FDA Received Date12/16/2020
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; CANCELLOUS BONE SCREW 6.5X25MM; CANCELLOUS BONE SCREW 6.5X35MM; DUR MAR NEUT LINER 28IDX54OD; DURALOC 1200 SERIES 54MM OD; SUMMIT DUOFIX TAP SZ6 STD OFF; UNK HIP LOCKING RING; ARTICUL/EZE BALL 28 +5 BR; CANCELLOUS BONE SCREW 6.5X25MM; CANCELLOUS BONE SCREW 6.5X35MM; DUR MAR NEUT LINER 28IDX54OD; DURALOC 1200 SERIES 54MM OD; SUMMIT DUOFIX TAP SZ6 STD OFF; UNK HIP LOCKING RING
Outcome Attributed to Adverse Event Required Intervention;
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