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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DLT TS CER HD 12/14 36MM +5.0; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 DLT TS CER HD 12/14 36MM +5.0; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136536720
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Swelling (2091); Tissue Damage (2104)
Event Type  Injury  
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
After review of medical records, patient had left hip ultrasound-guided aspiration non-joint checked, with an indication of metallosis.Mr pelvis-soft tissue reported localized swelling and patient's left hip of recurrent areas with consistent metallosis.It was also reported that there is a pressure erosion of the ischial tuberosity.Doi: (b)(6) 2016; dor: not reported; left hip.
 
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).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
DLT TS CER HD 12/14 36MM +5.0
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8315797
MDR Text Key135382852
Report Number1818910-2019-83592
Device Sequence Number1
Product Code LZO
UDI-Device Identifier10603295033660
UDI-Public10603295033660
Combination Product (y/n)N
PMA/PMN Number
K071830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/17/2019
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 Date09/30/2020
Device Catalogue Number136536720
Device Lot Number8203522
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/17/2019
Initial Date FDA Received02/07/2019
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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