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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136536320
Device Problems Material Disintegration (1177); Metal Shedding Debris (1804)
Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330)
Event Date 01/04/2018
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 record alleges friction and wear, large amounts of toxic cobalt and chromium metal ions, pain, discomfort, functional difficulties and elevated metal levels.Doi: (b)(6) 2005; dor: not reported; left hip (pinnacle).
 
Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
Manufacturer Narrative
Product complaint # (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
Update ad 7 aug 2018: (b)(4) has been re-opened due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges infection requiring antibiotics, pseudotumor, abductor muscle repair, and metallosis.Doi: (b)(6) 2005 ¿ dor: none reported (left hip).
 
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.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
DELTA CER HEAD 12/14 36MM +5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7218133
MDR Text Key98183556
Report Number1818910-2018-52000
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K031803
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 01/04/2018
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 Date02/28/2010
Device Catalogue Number136536320
Device Lot Number1867279
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/04/2018
Initial Date FDA Received01/25/2018
Supplement Dates Manufacturer Received02/21/2018
12/30/2018
12/30/2018
07/24/2019
Supplement Dates FDA Received02/21/2018
01/03/2019
01/10/2019
08/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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