MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CROWN CUP CLSTR HOLE 60MM GROUP 4

Model Number	180-01-60
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: (cn: 130-36-54, sn: unk) - novation gxl liner, natural, 36mm id.
Event or Problem Description
During the investigation of mfr 1038671-2020-00254 it was discovered that this patient had a revision of exactech derives in the right hip due to loosening and instability.Initial implant: (b)(6) 2007, revision : (b)(6) 2011.A search of the complaint system did not find a match.This case file was opened to capture that event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral stem and subsequent instability.However, this cannot be confirmed because the components were not returned for evaluation.(d11) concomitant device: - (cn: 130-36-54, sn: unk) - novation gxl liner, natural, 36mm id.No information provided in the following section(s): a4 a5, b6, d4 (serial number, exp date), g5, and h4.The following section(s) have additional info; g4, g7, h1, h2, h3, and h7.

• Brand Name: NOVATION
• Common Device Name: NV CROWN CUP CLSTR HOLE 60MM GROUP 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10129978
• Report Number: 1038671-2020-00297
• Device Sequence Number: 14304554
• Product Code: JDI
• UDI-Device Identifier: 10885862037053
• UDI-Public: 10885862037053
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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 Model Number: 180-01-60
• Device Catalogue Number: 180-01-60
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 98