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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS STEM CLRD HO 4; HIP IMPLANT FEMORAL STEM

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DEPUY IRELAND - 3015516266 EMSYS STEM CLRD HO 4; HIP IMPLANT FEMORAL STEM Back to Search Results
Catalog Number 474204200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limb Fracture (4518)
Event Date 02/26/2024
Event Type  Injury  
Event Description
Study no: dots.Clinical adverse event received for periprosthetic fracture - femoral.Event is serious and is considered mild.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2024; date of event: (b)(6) 2024; (left hip).Treatment: open reduction internal fixation.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
 
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Brand Name
EMSYS STEM CLRD HO 4
Type of Device
HIP IMPLANT FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 3015516266
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18861448
MDR Text Key337182236
Report Number1818910-2024-05389
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295505556
UDI-Public10603295505556
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2024
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 Catalogue Number474204200
Device Lot Number3685073
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/29/2024
Initial Date FDA Received03/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ARTICULEZE HD CER 36OD +5; EMSYS LNR AOX +4N 48X36; EMSYS SHL 3HOLE 48
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexFemale
Patient Weight77 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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