MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LNR, LIPPED, 32MM ID, GROUP 3 CUPS

Catalog Number	132-32-53
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 12/14 zirconia head 32mm +3.5mm neck (cat# 148-32-03 / sn# (b)(4)).
Event or Problem Description
As reported, the patient was initially implanted on (b)(6) 2009.A left hip ct and x-ray showed a tremendous amount of osteolysis.The surgeon revised the (b)(6) male¿s liner to an e-poly and replaced the head.Patient was last known to be in stable condition following the event.All available information received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported was likely the result of osteolysis that developed while being implanted for approximately ten years.(d11) concomitant device(s): - 12/14 zirconia head 32mm +3.5mm neck (cat# 148-32-03 / sn# (b)(6).

• Brand Name: NOVATION
• Common Device Name: NV GXL LNR, LIPPED, 32MM ID, GROUP 3 CUPS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9519564
• Report Number: 1038671-2019-00625
• Device Sequence Number: 2707934
• Product Code: JDI
• UDI-Device Identifier: 10885862023322
• UDI-Public: 10885862023322
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2013
• Device Catalogue Number: 132-32-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR