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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 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 Metal Shedding Debris; Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

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 received. Litigation alleges friction and wear between the cobalt- chromium metal head and liner caused high metal ions, and particles to be released into the patient¿s body resulting to injuries, pain, discomfort, soreness, tissue and bone loss, metallosis, mental suffering, mental anguish, psychological trauma, emotional distress and inability to perform normal daily activities. Laboratory confirmed elevated cobalt and chromium levels in the blood as a result of the metal on metal abrasion problem. There were no lab values provided. Doi: (b)(6) 2010; dor: not reported; right hip. This complaint is bilateral link to (b)(4).

 
Manufacturer Narrative

Product complaint # : (b)(4). 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 will be filed as appropriate.

 
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. 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 NameDELTA CER HEAD 12/14 36MM +5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork LS11 8DT
EI  LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key7517853
Report Number1818910-2018-59704
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device Catalogue Number136536320
Device LOT Number3169459
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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