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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 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-32-310
Device Problems Adverse Event Without Identified Device or Use Problem; Noise, Audible
Event Date 07/13/2019
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

A review of the provided video link is able to identify a loud audible squeaking noise as the patient bends and straightens the left leg.

 
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. (b)(4).

 
Event Description

Patient mag underwent left hip total arthroplasty surgery due to genetic malformation. On (b)(6) 2017, the patient underwent surgery for insertion of the prosthesis in the left hip. After the aforementioned surgery, the patient presented an excellent evolution and recovery, with no complications until (b)(6) 2019. It happens that, on (b)(6) 2019, the patient, for no apparent reason, presented a sudden pain and functional disability of the previously operated hip, which is why she informed the doctor in charge of her surgery, who advised her to go immediately to (b)(6) hospital, where the first surgery had taken place. According to a medical report provided by the same professional who performed both surgeries, after analyzing clinical and imaging examinations, it was found that urgent surgery was necessary, as there was a subluxation of the femoral component head, unsuccessfully attempting a ¿bloodless reduction¿. ¿as the material presented gross instability, that is, a displacement of the prosthesis was found and a replacement was attempted, but as the instability remained, a revision of the arthroplasty was indicated, requiring the replacement of the prosthesis. On (b)(6) 2019, surgeon underwent the second surgery in which, to his surprise, a fracture / rupture of the polyethylene was found, that is, the prosthesis had ruptured inside her body, so the pain, as well as instability and the functional disability suddenly suffered by it. The patient, up to the date of hospitalization, had a good adaptation to the prosthesis, not having suffered any fall, impact, accident, anything that would justify the rupture of such a resistant material. Which should last at least 30 years and ruptured in just 2 years. As there is a period of adaptation of approximately 3 (three) months from the organism to the prosthesis, on (b)(6) of the current year, the second prosthesis left the place, which resulted in a second hospitalization of 1 (one) day for the relocation of the prosthesis. The ruptured prosthesis, removed during the second surgery, was discarded by the hospital.

 
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Brand NameDELTA CER HEAD 12/14 32MM +1
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg, ringaskiddy co.
cork, munster
EI 
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46582-0988
6107428552
MDR Report Key9565303
Report Number1818910-2020-01111
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-32-310
Device Catalogue Number136532310
Device LOT Number8361785
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2016
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: 01/08/2020 Patient Sequence Number: 1
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