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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
Model Number 1010-12-040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that patient had right total hip revision related to infection.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Right hip.
 
Manufacturer Narrative
Product complaint # (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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing 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
MDR Report Key12192387
MDR Text Key262419882
Report Number1818910-2021-15464
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295380566
UDI-Public10603295380566
Combination Product (y/n)N
PMA/PMN Number
K150862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/30/2021
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 Number1010-12-040
Device Catalogue Number101012040
Device Lot NumberJC1501
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received08/12/2021
Supplement Dates FDA Received08/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACTIS COLLARED HIGH SIZE 4; ALTRX NEUT 32IDX48OD; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MULTIHOLE W/GRIPTION 48MM
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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