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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 +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-330
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/11/2020
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
It was reported that the patient had an apparent infection of the right hip.The surgeon removed all implants and performed and washout & i.D.And implanted an antibiotic cement spacer.Doi: (b)(6) 2019 (stem, cone, head), doi: (b)(6) 2017 (cup, liner, 2 screws), dor: (b)(6) 2020, affected side: right hip.
 
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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or sterilization that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DELTA CER HEAD 12/14 36MM +8.5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11087182
MDR Text Key224057961
Report Number1818910-2020-27715
Device Sequence Number1
Product Code LZO
UDI-Device Identifier10603295033639
UDI-Public10603295033639
Combination Product (y/n)N
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2020
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 Model Number1365-36-330
Device Catalogue Number136536330
Device Lot Number9228644
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received01/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALTRX +4 NEUT 36IDX54OD.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN SECTOR W/GRIPTION 54MM.; RECLAIM DISTAL TAPERED 15X190.; RECLAIM PRX BDY CONE 24X85.; ALTRX +4 NEUT 36IDX54OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 54MM; RECLAIM DISTAL TAPERED 15X190; RECLAIM PRX BDY CONE 24X85
Patient Outcome(s) Required Intervention;
Patient Age48 YR
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