• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem Noise, Audible (3273)
Patient Problem Foreign Body Reaction (1868)
Event Date 05/27/2022
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
Reported on 15th march 2022; 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. Please see photos attached to this email. New information as of today 27th may 2022: the patient was ¿doing well¿ at the six-week post operative check-up according to the physicians notes, but within a week, presented at clinic reporting a ¿clicking and grinding¿ sound and sensation, but no pain. A repeat x ray showed that the liner had disassociated, reason unknown. The physicians¿ notes suggest that there may be some ¿issue with the locking mechanism of the liner into the shell¿. On commencement today, there was metallosis in the joint, samples were sent for culture and sensitivity. The implants were successfully removed and alternate implants used. Please see attached x rays taken on (b)(6) 2022, prior to the dislocation of the liner from the cup and then on (b)(6) 2022, where the dislocation is evident. Please see attached images of the cup, liner and head which were removed. Doi: (b)(6) 2021; dor: (b)(6) 2022; right hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14685257
MDR Text Key293935314
Report Number1818910-2022-10823
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 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1365-32-720
Device Catalogue Number136532720
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/14/2022 Patient Sequence Number: 1
Treatment
DLT TS CER HD 12/14 32MM +5; PINN MAR NEUT 32IDX52OD; PINN SECTOR W/GRIPTION 52MM
-
-