MAUDE Adverse Event Report: Exactech, Inc. NV CROWN CUP CLSTR HOLE 56MM GROUP 3; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu

Catalog Number	180-01-56
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.As reported, due to the manufacturer's recall campaign, the patient that is five (5) years post-op the initial total hip arthroplasty, came in to have the hip prosthesis checked.Radiograph control revealed a clear decentering of the prosthetic head and unusually coarse osteolysis in the acetabulum as signs of premature inlay deterioration.The socket component was completely loosened.The patient was revised to another manufacturer's construct.No additional information is available.

• Brand Name: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu
• Manufacturer (Section D): Exactech, Inc.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): Exactech,Inc.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 50669729
• Report Number: 1038671-2026-01138
• Device Sequence Number: 9512525
• Product Code: MEH
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2022
• Device Catalogue Number: 180-01-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 07/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male