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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 Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Sepsis (2067); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Date 04/27/2018
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.(b)(6).
 
Event Description
Pinnacle litigation records received.Litigation alleges toxic cobalt-chromium metal debris to be released into patient's soft tissue surrounding the implant.The patient began to have difficulty with normal everyday tasks, experienced extreme pain, difference in leg length made walking difficulty and there was also a grinding sensation present while walking.Sitting and standing caused her extreme discomfort.The surgeon informed her that she had elevated metal ions.During revision surgery it was discovered that the implant had caused significant metallosis in the soft tissues and blackened discolored tissue throughout the hip.Doi: (b)(6) 2007: dor: (b)(6) 2018 (right hip).
 
Manufacturer Narrative
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.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.
 
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.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
Patient communication received.As stated " received a metal on metal hip replacement 2006.Went for 12 years to multiple doctors who refused to take care of me.Severe worsening pain from the day it was placed until 2018.In this time i experienced pain, neuropathy, rashes, itching,anxiety ,depression,cognitive issues.Made fun for years because of the noises the hip made with every step.All doctors ever did were x-rays and they always stated the hip was in place.The fda allowed this device into the market and i have been severely injured and have lifelong disabilities because of the metal on metal hip.Now, completely unable to return to my career as a registered nurse,metal levels over 49,sepsis, pseudotumors, necrosis and bone loss.Antibiotic spacer placed 2018 for over 8 months and revision on 2018.All completed at medical center".
 
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 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. .
 
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
Pff alleges metal wear, metallosis and elevated metal ions.After review of medical records, patient was revised to address pain due to prosthetic infection and metallosis without loosening and with retroacetabular and limited proximal femoral osteolysis.It was also reported of minor posterior edge greater trochanter fracture and medial wall acetabular fractures.Added expiration date, manufactured date, product and lot details of head and liner.Added manufactured date, product and lot details of stem.Added patient age and dob.Updated patient initials.
 
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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 Key7822019
MDR Text Key118395270
Report Number1818910-2018-67831
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2012
Device Catalogue Number136551000
Device Lot Number2400407
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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