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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/18/2022
Event Type  Injury  
Event Description
Revision completed due to active infection. Surgeon made the decision to remove all implants and implant antibiotic spacers. Doi: (b)(6) 2021. Doe: (b)(6) 2022. Affected side: unk.
 
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 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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key13997886
MDR Text Key288589764
Report Number1818910-2022-06107
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 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1010-12-040
Device Catalogue Number101012040
Device Lot NumberJC7298
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2021
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: 04/04/2022 Patient Sequence Number: 1
Treatment
ALTRX NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE 300 ACET CUP 52MM
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