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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM STM ST 36+12L 21X26X175; S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US S-ROM STM ST 36+12L 21X26X175; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 563626
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limb Fracture (4518)
Event Date 09/07/2023
Event Type  Injury  
Event Description
Clinical adverse event received for small non-displaced distal femur fracture.Event is not serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2023.Date of event: (b)(6) 2023.(left hip).
 
Manufacturer Narrative
Product complaint #: (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.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
S-ROM STM ST 36+12L 21X26X175
Type of Device
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI  
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key17842192
MDR Text Key324556154
Report Number1818910-2023-19620
Device Sequence Number1
Product Code MRA
UDI-Device Identifier10603295178262
UDI-Public10603295178262
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 09/29/2023
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 Number563626
Device Lot Number9658953
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2023
Initial Date FDA Received09/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2020
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
11/13 S-ROM 40MM M SPEC+9; EMSYS LNR AOX +4N 60-62X40; EMSYS SHL 3HOLE 60; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; SROM*SLEVE ZTT UNSZ 24F XL26ID
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient SexMale
Patient Weight132 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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