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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED STD SIZE 3; HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US ACTIS COLLARED STD SIZE 3; HIP FEMORAL STEM Back to Search Results
Catalog Number 101011030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/10/2024
Event Type  Injury  
Event Description
Patient got an infection post surgery.There was no added time to the surgery.No instruments were broken during the surgery.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: right hip.
 
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 101011030/lot m07x59 combination.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 101011030/lot m07x59 combination.
 
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Brand Name
ACTIS COLLARED STD SIZE 3
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18926702
MDR Text Key337945121
Report Number1818910-2024-05855
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10603295380436
UDI-Public10603295380436
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 03/18/2024
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 Number101011030
Device Lot NumberM07X59
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2024
Initial Date FDA Received03/18/2024
Supplement Dates Manufacturer Received04/11/2024
Supplement Dates FDA Received04/15/2024
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
BI MENTUM ALTRX LNR 49 28; DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE DM LINER 56_49
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexFemale
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