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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-730
Device Problems Naturally Worn; Noise, Audible
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. (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 primary tha was on (b)(6) 2016 by dr. At (b)(6) health. Revision tha was on (b)(6) 2016 by dr. At (b)(6) health (head and liner revised, acetabular screw removed). The patient came to the orthopedic urgent care located in (b)(6). Clinic complaining of pain. X-rays revealed what appeared to be a failure at the interface of the acetabular shell and poly liner. If accurate, this would be the second such dissociation for this patient since the original surgery in 2016. The poly and head were revised in 2018 for the same indication. The patient is adamant that this is a failure on the part of depuy and has indicated that she will be seeking legal remedy against depuy. Revision surgery is indicated and will be performed by dr. (date to be determined). The patient has indicated that her preference would be that no depuy products are to be used in the revision. Please bring this to the attention of legal.

 
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Brand NameDLT TS CER HD 12/14 36MM +8.5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg ringaskiddy
cork
EI 
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9953912
Report Number1818910-2020-10647
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-36-730
Device Catalogue Number136536730
Device LOT Number8562734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/13/2020 Patient Sequence Number: 1
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