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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136536320
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 08/20/2019
Event Type  Injury  
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

Revision total hip replacement; (b)(6) hospital 20/08/2019. Primary surgery in (b)(6) in 2016. Revision of ceramic on ceramic articulation for squeaking and pain. Articulation revised to ceramic on polyethylene. Male patient initials (b)(6); limited information available due to primary implanted interstate. Unknown jrn: 58mm pinnacle ceramic biolox acetabular liner - discarded; 36mm biolox ceramic head = discarded; 58mm pinnacle acetabular cup = still implanted; corail collarless femoral component = still implanted.

 
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Brand NameDELTA CER HEAD 12/14 36MM +5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8982698
MDR Text Key161690051
Report Number1818910-2019-103779
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number136536320
Device LOT Number8062435
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 Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2015
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: 09/10/2019 Patient Sequence Number: 1
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