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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 5 HIP FEMORAL STEM

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DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 5 HIP FEMORAL STEM Back to Search Results
Model Number 1010-11-050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Date 04/29/2021
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
It was reported that one day after right tha, surgeon brought patient back to operating room to correct offset and leg length issue. Surgeon removed 5 std actis and replaced with a 4 std actis. Surgeon removed 36 + 1. 5 head and replaced with 36 -2. Cup and liner remained implanted. Doi: (b)(6) 2021; dor: (b)(6) 2021; affected side: right hip.
 
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Brand NameACTIS COLLARED STD SIZE 5
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
6107428552
MDR Report Key11818825
MDR Text Key250422504
Report Number1818910-2021-10173
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1010-11-050
Device Catalogue Number101011050
Device Lot NumberJC0011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
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: 05/13/2021 Patient Sequence Number: 1
Treatment
CUP; DELTA CER HEAD 12/14 36MM +1.5; LINER
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