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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 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-32-310
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868)
Event Date 12/15/2020
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

Primary operative notes (b)(6) 2015 indicate the patient received a right total hip replacement due to end stage osteoarthritis. The surgery was completed without indication of complication by the surgeon. Revision operative notes (b)(6) 2020 indicate the patient received a right total hip revision of the head and liner due to hip squeaking and polyethylene liner wear. Upon entering the joint, blackened tissue and adhesions were encountered and removed. The femoral head shows considerable black stripe wear from contact with the cup through the worn liner. The surgery was completed without indication of complication by the surgeon. It should be noted that the patient has also received a left total hip with left hip revision. However, at the time of this review, it is unknown if the left hip components are depuy.

 
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Brand NameDELTA CER HEAD 12/14 32MM +1
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)
DEPUY IRELAND - 9616671
loughbeg, ringaskiddy co
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11660910
MDR Text Key247628725
Report Number1818910-2021-07849
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-32-310
Device Catalogue Number136532310
Device LOT Number8042091
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/19/2014
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: 04/13/2021 Patient Sequence Number: 1
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