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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +15.5; HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +15.5; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136555000
Device Problems Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Osteolysis (2377)
Event Date 12/05/2014
Event Type  Injury  
Event Description
Patient was revised to address pain, metallosis, osteolysis, a malpositioned cup due to migration, and cup loosening.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.X-rays were received and reviewed.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
This report is still under investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
 
Manufacturer Narrative
No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.X-rays were received and reviewed.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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.
 
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Brand Name
ARTICULEZE M HEAD 36MM +15.5
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key4372245
MDR Text Key18895308
Report Number1818910-2014-35463
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
PK120599
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor,consumer,distributor,he
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/09/2015
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 Catalogue Number136555000
Device Lot Number2858917
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/07/2015
Initial Date FDA Received12/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
11/28/2019
Supplement Dates FDA Received02/05/2015
05/13/2015
12/12/2015
01/15/2016
12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight106
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