MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CROWN CUP CLSTR HOLE 54MM GROUP 2

Catalog Number	180-01-54
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): nv gxl lnr, lipped 32mm id group 2 cups (cat# 132-32-52).
Event or Problem Description
As reported by a hip replacement study, the patient was initially implanted with tha on (b)(6) 2014.The patient presented on (b)(6) 2019 for follow-up visit with left groin pain and fixed component.A follow up x-rays noted osteolysis with peri-acetabular implant associated.Revision was completed on (b)(6) 2019 on left hip.
Event or Problem Description
As reported by a hip replacement study, approximately 5 years post-op tha, the 57 y/o male patient presented with left groin pain and fixed component.A follow up x-rays noted osteolysis with peri-acetabular implant associated.A revision of the left hip was completed and found loosening.Devices will not be returned.This patient¿s historical information indicates there were no comorbidities.Patient was discharged after 2 days to at home case with a walker.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported was likely the result of underlying patient factors, which led to the pain and fixation of the joint.(d11) concomitant device(s): nv gxl lnr, lipped 32mm id group 2 cups (cat# 132-32-52).

• Brand Name: NOVATION
• Common Device Name: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9520730
• Report Number: 1038671-2019-00629
• Device Sequence Number: 19586308
• Product Code: JDI
• UDI-Device Identifier: 10885862037022
• UDI-Public: 10885862037022
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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 Catalogue Number: 180-01-54
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 06/26/2020
• 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: 57 YR
• Patient Weight: 60