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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 09/30/2020
Event Type  Injury  
Manufacturer Narrative
H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.
 
Event Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2018 and then experienced a revision surgical procedure on (b)(6) 2020 approximately 2 years and 2 months after initial implant.There is no device information provided.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.
 
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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 Key18951318
MDR Text Key338259935
Report Number1038671-2024-00627
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 Received09/28/2023
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;
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