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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 32MM +9 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 DLT TS CER HD 12/14 32MM +9 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136532730
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 12/11/2018
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

It was reported that patient was previously a repeat dislocator. After close to a year of no repeat problems, patient noticed a squeaking noise and was x-rayed. Looked as though she had dislocated again and head was resting on lip of 10 degrees. Liner. During surgery it was found that the liner had fractured in two pieces and possibly had disassociated from the cup while in patient. Noticed damage on various parts of liner, marks on a head from metal on ceramic articulation. Cup was well fixed. Patient was revised to larger cup and larger head.

 
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.

 
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Brand NameDLT TS CER HD 12/14 32MM +9
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
EI
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8228915
MDR Text Key132436263
Report Number1818910-2019-80243
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number136532730
Device LOT Number7131188
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/06/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2019 Patient Sequence Number: 1
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