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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CROWN CUP GXL ACETABULAR LINER, LIPPED
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EXACTECH, INC. NOVATION CROWN CUP GXL ACETABULAR LINER, LIPPED Back to Search Results
Catalog Number 132-28-52
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/05/2014
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
Index surgery: (b)(6) 2014.Patient presented with prosthesis luxation with posterior pain and functional limitation due to a fall.Closed reduction was performed with success.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
This device is used for treatment not diagnosis.
 
Event Description
Left hip closed reduction.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00249, 1038671-2018-00251, 1038671-2018-00252 and 1038671-2018-00253.
 
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Brand Name
NOVATION CROWN CUP GXL ACETABULAR LINER, LIPPED
Type of Device
ACETABULAR LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
MDR Report Key6536484
MDR Text Key74162372
Report Number1038671-2017-00250
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K070479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number132-28-52
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age64 YR
Patient Weight79
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