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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED HIGH SIZE 4; HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US ACTIS COLLARED HIGH SIZE 4; HIP FEMORAL STEM Back to Search Results
Catalog Number 101012040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/29/2023
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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.
 
Event Description
The patient was revised due to infection.Unknown surgical delay.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).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.
 
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Brand Name
ACTIS COLLARED HIGH SIZE 4
Type of Device
HIP FEMORAL STEM
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
3035526892
MDR Report Key18435732
MDR Text Key331801749
Report Number1818910-2024-00216
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295380566
UDI-Public10603295380566
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/03/2024
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 Number101012040
Device Lot Number4175992
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/29/2023
Initial Date FDA Received01/03/2024
Supplement Dates Manufacturer Received01/19/2024
Supplement Dates FDA Received01/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
DLT TS CER HD 12/14 40MM +5.0; EMSYS LNR AOX N 54X40; EMSYS SHL 3HOLE 54; PINN CAN BONE SCREW 6.5MMX25MM
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexMale
Patient Weight107 KG
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