MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS

Model Number	132-36-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: cocr fem head 36mm +0 (b)(4).
Event or Problem Description
As reported, approximately 5.5 years postop the initial implant, this (b)(6) y/o male patient¿s left hip was revised for poly exchange with small amounts of wear.Patient was last known to be in stable condition following the event.Device not returning due to hospital throwing away.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the result of prosthesis wear which may have been due to orientation of the acetabular cup, edge loading/impingement, and/or patient related factors.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device: - cocr fem head 36mm +0 (cn: 142-36-00, sn: (b)(6) ) no information provided in the following section(s): a4, a5, b6.The following section(s) have additional info; g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: NOVATION
• Common Device Name: NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10299154
• Report Number: 1038671-2020-00358
• Device Sequence Number: 3458830
• Product Code: JDI
• UDI-Device Identifier: 10885862023438
• UDI-Public: 10885862023438
• Combination Product (Y/N): N
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 10/28/2017
• Device Model Number: 132-36-54
• Device Catalogue Number: 132-36-54
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: Required Intervention
• Patient Age: 50 YR