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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US 1818910 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136506000
Device Problems Material Discolored (1170); Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Event Date 10/01/2018
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
Pinnacle litigation record received.Litigation alleged injury, degenerative pain, soreness, and difficulty of walking.
 
Manufacturer Narrative
(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Ppf alleges metal wear and 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).
 
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 pain.After review of medical records, patient was revised to address pain with trunnionosis.Revision notes stated that 5cc of pink serosanguinous fluid was aspirated, some soft tissue reaction was also noted with a very thickened synovium.There was an evidence of trunnionosis, black particulate matter inside the metal femoral head.Added patient dob, age, weight and height.Added revision surgeon and hospital.Added manufactured date, expiration date, product and lot details of the head and liner.
 
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Brand Name
12/14 ARTICUL 40MM M SPEC+5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7995589
MDR Text Key124718436
Report Number1818910-2018-73249
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K060031
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 10/03/2018
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 Date03/31/2012
Device Catalogue Number136506000
Device Lot Number2361062
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/03/2018
Initial Date FDA Received10/23/2018
Supplement Dates Manufacturer Received11/14/2018
03/05/2019
03/19/2019
Supplement Dates FDA Received11/14/2018
03/14/2019
04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight66
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