MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 54MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	180-01-54
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 132-32-52 - nv gxl lnr, lipped 32mm id group 2 cups, (b)(6) - 160-00-14 - pf stem tapered plasma sz 14, (b)(6) - 170-32-93 - biolox delta femoral head 32mm od, -3.5mm, (b)(6) - 120-65-20 - bone screw 6.5mm dia x 20mm long, (b)(6) - 600-05-90 - opteform disc-90mm, (b)(6) - 600-05-90 - opteform disc-90mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02566.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 123 months after a left total hip replacement procedure, the patient underwent a revision procedure to address a failed cup and liner.An image and x-ray were provided.Patient was revised to exactech devices.Patient was last known to be in stable condition following the event.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c.The revision reported was likely the result of prosthesis wear over the course of 10 years of implantation, patient-related considerations, and a combination of the risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) including edge loading and impingement.An additional reason for the revision may be acetabular cup loosening, but this cannot be confirmed as the devices were not returned for evaluation and no clinical notes were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22889331
• Report Number: 1038671-2025-02826
• Device Sequence Number: 20068489
• Product Code: MEH
• UDI-Device Identifier: 10885862037022
• UDI-Public: 10885862037022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 05/05/2017
• Device Catalogue Number: 180-01-54
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 05/10/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male