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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136553000
Device Problems Material Disintegration (1177); Naturally Worn (2988)
Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)
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.Concomitant medical products: articuleze m head 36mm +8.5 hip femoral head.Pinnacle mtl ins neut36idx52od hip acetabular liner.Unknown hip acetabular cup.Summit por taper sz5 hi off hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.
 
Event Description
New unity record created in order to update legacy complaint number (b)(4).Litigation papers allege the following: after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in his left thigh and groin.He also experienced a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Patient will likely need to undergo revision surgery to replace the implant.Doi: (b)(6) 2004; dor: none reported; (left side).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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 Name
ARTICULEZE M HEAD 36MM +8.5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8DT
UK   LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8028377
MDR Text Key125791104
Report Number1818910-2018-74185
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033950
UDI-Public10603295033950
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2009
Device Catalogue Number136553000
Device Lot Number1229261
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/07/2018
Initial Date FDA Received11/01/2018
Supplement Dates Manufacturer Received04/30/2019
Supplement Dates FDA Received04/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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