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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 4 HIP FEMORAL STEM

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DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 4 HIP FEMORAL STEM Back to Search Results
Model Number 1010-12-040
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
(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 when the circulator opened the actis stem implant box, she noticed that the side of the blister pack was broken. She did not present the implant to the sterile field or peel back the sterile package. All pieces broken from the blister pack were recovered in the box and there was no patient involvement. Another implant was used as a replacement. I am returning the implant in its original packaging. Doe: (b)(6) 2021.
 
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Brand NameACTIS COLLARED HIGH SIZE 4
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
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11748256
MDR Text Key248157632
Report Number1818910-2021-09207
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1010-12-040
Device Catalogue Number101012040
Device Lot NumberJ99Y01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2021
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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