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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-02-135
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 07/15/2020
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
It was reported that the joint was infected, components removed and placement of an antibiotic spacer.Stem was loose at bone to implant interface due to infection, cup was well fixed.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: left 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.
 
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Brand Name
SUMMIT DUOFIX TAP SZ7 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 Key10318404
Report Number1818910-2020-16785
Device Sequence Number3557414
Product Code LPH
UDI-Device Identifier10603295059486
UDI-Public10603295059486
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 Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/15/2020
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 Number1570-02-135
Device Catalogue Number157002135
Device Lot NumberJ3183X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/15/2020
Supplement Date Received by Manufacturer08/25/2020
Initial Report FDA Received Date07/24/2020
Supplement Report FDA Received Date08/26/2020
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
12/14 ARTICUL 40MM M SPEC+1.5; ALTRX NEUT 40IDX58OD; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 58MM; SUMMIT DUOFIX TAP SZ7 STD OFF; 12/14 ARTICUL 40MM M SPEC+1.5; ALTRX NEUT 40IDX58OD; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 58MM; SUMMIT DUOFIX TAP SZ7 STD OFF
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
Patient Weight131
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