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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136552000
Device Problem Naturally Worn (2988)
Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)
Event Date 01/30/2018
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.
 
Event Description
Der stated that the patient had metal liner removed and was given an altrx liner and a ts ceramic head.Doi: 2003; dor: (b)(6) 2018; left hip.No surgical delay.
 
Manufacturer Narrative
Pc-(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.
 
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
Pfs alleges difficulty ambulating.After review of medical records, patient was revised to address failed left total hip arthroplasty with possible trunnionosis.On 1/30/2018, the visual evaluation for the capsule about the rim of the acetabulum appeared to be uninflamed.After extracting the liner from acetabular shell, they noted that it has no wear, metallosis and corrosion.Morse taper have the same results.Laboratory results for cobalt-chromium were also provided, these confirmed that there was no high metal ions in the patients blood.
 
Event Description
Ppf alleges metal wear/metallosis.
 
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).
 
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Brand Name
ARTICULEZE M HEAD 36MM +5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7805430
MDR Text Key117879962
Report Number1818910-2018-67405
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
Report Date 07/31/2018
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 Date09/30/2009
Device Catalogue Number136552000
Device Lot Number1237380
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/31/2018
Initial Date FDA Received08/22/2018
Supplement Dates Manufacturer Received10/17/2018
02/11/2019
03/09/2019
Supplement Dates FDA Received10/18/2018
02/13/2019
03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient Weight70
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