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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED STD SIZE 6 HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US 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 Unspecified Infection (1930)
Event Date 03/30/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Revision completed due to infection. Doi: unknown. Dor: (b)(6) 2022. Affected side: right.
 
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Brand NameACTIS COLLARED STD SIZE 6
Type of DeviceHIP 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 46581-0988
3035526892
MDR Report Key14135885
MDR Text Key289442562
Report Number1818910-2022-06839
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150862
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 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1010-11-060
Device Catalogue Number101011060
Device Lot NumberJ7111Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2022 Patient Sequence Number: 1
Treatment
ALTRX NEUT 32IDX50OD.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX30MM.; PINNACLE SECTOR II CUP 50MM.; PINNACLE SECTOR II CUP 50MM.
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