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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 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-32-720
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Discomfort (2330)
Event Date 03/15/2022
Event Type  Injury  
Event Description
The patient had right hip arthroplasty surgery in (b)(6) 2021. After approximately two months, the patient reported hearing a ¿click¿ but continued to walk on the hip without seeking help at that time. The patient then complained that the hip was ¿squeaking¿ and sore and sought help. There was evidence of metallosis shortly after skin incision, the acetabular liner had dislocated from the acetabular shell and the ceramic head showed significant wear. The procedure was made considerably more complicated as the head was reportedly ¿stuck¿ in the liner and it was difficult to dislocate the hip. It was necessary to use a saw to make a cut on the liner for the purpose of levering the liner to dislocate the hip and remove the head. Doi: (b)(6) 2021; dor: (b)(6) 2022; right hip.
 
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 +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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key13965461
MDR Text Key288287329
Report Number1818910-2022-05866
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K073570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1365-32-720
Device Catalogue Number136532720
Device Lot Number4541256
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
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: 03/31/2022 Patient Sequence Number: 1
Treatment
DLT TS CER HD 12/14 32MM +5; PINN MAR NEUT 50ODX32ID; UNKNOWN HIP ACETABULAR CUP
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