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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136551000
Device Problems Corroded (1131); Material Disintegration (1177); Naturally Worn (2988)
Patient Problems Host-Tissue Reaction (1297); Fall (1848); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 09/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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 will be filed as appropriate.Concomitant medical products: articuleze m head 36mm +1.5 hip femoral head; pinnacle mtl ins neut36idx52od hip acetabular liner; pinnacle mtl ins neut36idx52od hip acetabular cup; summit por taper sz5 std off hip femoral stem.Non-healthcare professional; attorney.
 
Event Description
Der states conversion of metal on metal liner to ceramic on poly.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Complaint description: der states conversion of metal on metal liner to ceramic on poly.Reopened due to receipt of pinnacle metal on metal litigation.Litigation alleges injury, pain, discomfort, inflammation, mental anguish, loss of mobility, loss of range of motion, distress, disfigurement, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner cause large amounts of toxic cobalt-chromium metal ions and particles to be released into patients blood, tissue, and bone surrounding the implant.
 
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.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.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. udi: (b)(4).
 
Event Description
Ppf alleges pseudotumor.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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.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, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pfs alleges difficulty walking and fall.After review of medical records, revision notes indicated a modest amount of gray stained fluid around the hip, a moderate amount of reactive gray stained synovium was noted, corrosion of the head and neck junction also was noted, there was no obvious wear of liner.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Patient code: no code available (3191) used to capture the surgical intervention and medical device removal.
 
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Brand Name
ARTICULEZE M HEAD 36MM +1.5
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
MDR Report Key7913803
MDR Text Key121852526
Report Number1818910-2018-70642
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033912
UDI-Public10603295033912
Combination Product (y/n)N
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/04/2018
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 Date10/31/2010
Device Catalogue Number136551000
Device Lot Number1987215
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/04/2018
Initial Date FDA Received09/27/2018
Supplement Dates Manufacturer Received09/04/2018
03/05/2019
08/05/2019
11/13/2019
11/26/2019
Supplement Dates FDA Received09/27/2018
03/13/2019
08/26/2019
11/22/2019
12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight54
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