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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-40-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)
Event Date 10/13/2017
Event Type  Injury  
Event Description
Litigation record received. Litigation alleges that the patient was diagnosed with fibroadipose tissue and focal synovium with chronic inflammation, hemosiderosis and metallosis. Doi: (b)(6) 2017. Dor: (b)(6) 2017. Right hip (second revision).
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSELF CENT HIP 40X28 RUST
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14336366
MDR Text Key291204040
Report Number1818910-2022-08435
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Model Number1035-40-000
Device Catalogue Number103540000
Device Lot NumberH73662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
Treatment
ALTRX +4 NEUT 40IDX64OD.; DELTA CER HEAD 11/13 28MM +6.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX8MM.; PINN MULTIHOLE W/GRIPTION 64MM.; SELF CENT HIP 40X28 RUST.; SROM*STM ST,36+8L NK,18X13X160.
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