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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US J-FX BIPOL SHELL&28MMLINR/49MM MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US J-FX BIPOL SHELL&28MMLINR/49MM MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number 856749
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/27/2021
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
It was reported that on (b)(6) 2021, the patient underwent the bha surgery for femoral neck fracture. The surgery was proceeded according to the surgical technique and completed without any problem. On (b)(6) the surgeon noticed the patient's numerical abnormality (details unknown), and re-operation was performed on the same day. The wound was opened, the implants were removed and thoroughly cleaned. The sample was sent for culture examination, but it was not clear whether it was a prosthetic joint infection. In the re-operation, cement spacer mold containing antibiotics was prepared and placed in the hip joint. The patient will be followed up for the next several weeks to confirm that the infection has subsided, and then revision surgery (bha or tha) will be scheduled. There is no opinion from the surgeon that this event was caused by the implants. The cause of this event could not be ruled out as being the sterilization of instruments before surgery, clean field management at the time of surgery, and bacteria that the patient already had, and many possibilities are assumed. Doi: (b)(6) 2021, dor: (b)(6) 2021, unknown side.
 
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Brand NameJ-FX BIPOL SHELL&28MMLINR/49MM
Type of DeviceMISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12488447
MDR Text Key271923789
Report Number1818910-2021-20410
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number856749
Device Lot NumberD20031375
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 Received10/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2021 Patient Sequence Number: 1
Treatment
ARTICUL/EZE BALL 28 +5 BR; CORAIL AMT COLLAR SIZE 12; J-FX BIPOL SHELL&28MMLINR/49MM
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