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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 28MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-28-330
Device Problems Fracture; Noise, Audible
Event Date 05/06/2020
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

Surgeon reported to (b)(6): "increasing pain in the right hip without trauma after getting up and audible cracking; preoperative radiological: ceramic head fracture after hip tep 15 years ago; intraoperatively: the most likely older event with fragments that are firmly encapsulated in the capsule / scar tissue, some freshly lying in the joint. ".

 
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Brand NameDELTA CER HEAD 12/14 28MM +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 ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key10092068
Report Number1818910-2020-12621
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 05/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-28-330
Device Catalogue Number136528330
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2020
Was Device Evaluated By Manufacturer? No
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: 05/27/2020 Patient Sequence Number: 1
Treatment
DELTA CER HEAD 12/14 28MM +8.5
PINN MAR LIP LNR 28IDX56OD
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