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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136531000
Device Problems Material Disintegration (1177); Biocompatibility (2886)
Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)
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
Litigation papers allege that after 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 right 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.Doi: (b)(6) 2005 - dor: none reported (left hip).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
S-ROM M HEAD 36MM +0
Type of Device
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8023368
MDR Text Key125605132
Report Number1818910-2018-73964
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033363
UDI-Public10603295033363
Combination Product (y/n)N
PMA/PMN Number
K120599
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 10/05/2018
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 Date01/31/2010
Device Catalogue Number136531000
Device Lot Number1850403
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/05/2018
Initial Date FDA Received10/31/2018
Supplement Dates Manufacturer Received04/30/2019
Supplement Dates FDA Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
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