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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-54-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Sepsis (2067)
Event Date 09/08/2022
Event Type  Injury  
Event Description
Clinical adverse event received for vascular pe and sepsis.Event is serious and is considered severe.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2022.(left knee).Treatment: unspecified injected medication.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
On (b)(6) 2022, the patient had a left press-fit total hip arthroplasty to address primary osteoarthritis, end-stage left hip.Depuy components were used during this procedure.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was received for examination.Based on the visual analysis of the provided photographic evidence for 136554000/articuleze m head 36mm +12.It cannot be determinate, a depuy's device failure or malfunction, which could contribute to reported event.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may 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
ARTICULEZE M HEAD 36MM +12
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key15494132
MDR Text Key300697681
Report Number1818910-2022-18803
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033974
UDI-Public10603295033974
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/27/2022
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
Device Operator Health Professional
Device Model Number1365-54-000
Device Catalogue Number136554000
Device Lot Number8687395
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2022
Initial Date FDA Received09/27/2022
Supplement Dates Manufacturer Received09/21/2022
11/10/2022
Supplement Dates FDA Received09/30/2022
11/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ALTRX +4 NEUT 36IDX56OD; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ6 HI OFF
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient SexFemale
Patient Weight113 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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