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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 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-330
Device Problems Material Disintegration (1177); Noise, Audible (3273)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Tissue Damage (2104); No Code Available (3191)
Event Date 04/17/2009
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. Concomitant med products: delta cer head 12/14 36mm +8. 5 hip femoral head; pinn mar +4 10d 36idx54od hip acetabular liner; unknown hip acetabular cup; summit por taper sz5 hi off hip femoral stem. (b)(4).

 
Event Description

Maude event report mw5025020 states: at my appointment with my surgeon, i was told that depuy pinnacle cup with metal on metal articulation (hip replacement) was failing after less than three years and had to be replaced within 6 months. A blood test revealed high levels of chromium and cobalt and an mri showed fluid collecting on the joint. It is also squeaking. My surgery is scheduled. Background: my left hip was replaced in 2007 with a depuy polyethylene system. According to my surgeon, the cup liner slipped out of position and began to disintegrated, necessitating hip revision surgery in 2009. The depuy pinnacle cup with metal articulation was implanted at that time. But 2012, my surgeon determined it too was failing. Ppf alleges metal wear, metallosis and pseudotumor. Added dob, head and stem. Doi: (b)(6) 2007; dor: (b)(6) 2009 (left hip) (head, liner). Dor: none reported (left hip) (stem).

 
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Brand NameDELTA CER HEAD 12/14 36MM +8.5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key8094256
MDR Text Key128023893
Report Number1818910-2018-76133
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2010
Device MODEL Number1365-36-330
Device Catalogue Number136536330
Device LOT Number1931885
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2005
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: 11/21/2018 Patient Sequence Number: 1
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