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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
Opened an actis size 6 std and the plastic. Patient consequence description/ was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? no patient consequence.
 
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.
 
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Brand NameACTIS COLLARED STD SIZE 6
Type of DeviceHIP 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
kara ditty-bovard
1210 ward av
west chester, PA 19380
6107428552
MDR Report Key13112915
MDR Text Key285179107
Report Number1818910-2021-28978
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 Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1010-11-060
Device Catalogue Number101011060
Device Lot NumberJH4439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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