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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-05-000
Device Problems Material Disintegration (1177); Naturally Worn (2988)
Patient Problems Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Date 11/20/2013
Event Type  Injury  
Manufacturer 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.(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 alleges metal wear, metallosis and elevated metal ions.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
Event Description
After review of medical records, it was indicated that the patient developed pain and elevated cobalt chromium blood level.Operative notes reported that there were pseudocyst, synovitis and a large osteophyte.Which was about half the size of a golf ball.
 
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.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.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.
 
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Brand Name
12/14 ARTICUL 40MM M SPEC+1.5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8190332
MDR Text Key131181415
Report Number1818910-2018-79034
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295032960
UDI-Public10603295032960
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
Report Date 02/12/2020
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 Date01/31/2013
Device Model Number1365-05-000
Device Catalogue Number136505000
Device Lot Number2535413
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received02/12/2020
03/10/2020
Supplement Dates FDA Received03/04/2020
03/10/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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