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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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EXACTECH, INC. HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Date 03/28/2024
Event Type  Injury  
Event Description
Complaint information received via a text message from a rep in the field requesting device identification from an x-ray and if there are liners available.It was identified as a accu match "a" series cup, and the neutral and 15° liners in xle are for them.It was stated that we are not sure what taper that it is because we can¿t really see the bottom of the taper on the femoral component and won¿t be able to tell, so it was suggested to have both liners available.Date of this revision is unknown.No further information.
 
Manufacturer Narrative
Section h10: (h3) pending evaluation.
 
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Brand Name
HIP COMPONENTS
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
matt collins
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key19154213
MDR Text Key340739436
Report Number1038671-2024-00926
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/22/2024
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 Sequence Number1
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