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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136532310
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Pain (1994); Discomfort (2330); Not Applicable (3189)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
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) surgical centre (b)(6) 2018. Patient presented after 6 weeks of discomfort with an audible squeak coming from her hip replacement. Upon dissection down to the joint replacement the polyethylene liner was found to be fractured into multiple pieces and the ceramic head showed signs of wear on the lip of the cup insitu. The head and liner components were removed and the integrity of the cup was inspected. The joint replacement was then re-trialled and new components were implanted leaving the primary stem and pinnacle cup insitu. Female patient dob: (b)(6).
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4). Investigation summary: examination of the femoral head does find evidence to support a disassociation event. Product error / contribution to the event is not identified. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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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. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key7446311
MDR Text Key106019813
Report Number1818910-2018-57881
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number136532310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
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: 04/20/2018 Patient Sequence Number: 1
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