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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 6; HIP FEMORAL STEM

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DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 6; HIP FEMORAL STEM Back to Search Results
Model Number 1010-11-060
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 01/09/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.
 
Event Description
Patient was revised due to pain.Doi: unknown.Dor: (b)(6) 2023.Affected side: left hip.
 
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Brand Name
ACTIS COLLARED STD SIZE 6
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
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 Key16214394
MDR Text Key307784017
Report Number1818910-2023-01621
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295380467
UDI-Public10603295380467
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
Report Date 01/20/2023
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 Model Number1010-11-060
Device Catalogue Number101011060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2023
Initial Date FDA Received01/20/2023
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
ACTIS COLLARED STD SIZE 6; ALTRX NEUT 36IDX54OD; DLT TS CER HD 12/14 36MM +5.0; PINN SECTOR W/GRIPTION 54MM
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight87 KG
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