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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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EXACTECH, INC. NOVATION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 11/02/2023
Event Type  Injury  
Event Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2015, and then experienced a revision surgical procedure on (b)(6)(2023, approximately 8 years, 5 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
 
Manufacturer Narrative
Pending investigation.There is no other information provided.
 
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Brand Name
NOVATION GXL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
michael crader
MDR Report Key18956200
MDR Text Key338309604
Report Number1038671-2024-00633
Device Sequence Number1
Product Code LZO
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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