MAUDE Adverse Event Report: Exactech, Inc. NV CROWN CUP CLSTR HOLE 48MM GROUP 1; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	180-01-48
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Aseptic loosening (4883)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury

• Brand Name: NV CROWN CUP CLSTR HOLE 48MM GROUP 1
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• 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: 50572095
• Report Number: 1038671-2026-01133
• Device Sequence Number: 9947199
• Product Code: LPH
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 02/06/2017
• Device Catalogue Number: 180-01-48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/09/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male