MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	130-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 180-11-48 - nv crown cup clsr hl w/ha 48mm group 1: (b)(6) 164-03-08 - element-stem, collared w/ha, std offset, sz 8: (b)(6) 01-032-03-3294 - universal cup, head, delta, 32mm, -4: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 65 yo female patient, who had an initial left tha, underwent a revision procedure approximately 6 years post the initial procedure.Pe wear + microparticle disease, pain during hip rotations reported.The cup with a model g7 50 prosthesis, with a ceramic-ceramic 32 l friction pair were replaced.The cystic areas were filled with bone graft.Intraoperative cultures are negative.Having followed a satisfactory evolution, he began ambulation 48 hours after surgery without complications and was discharged.Favorable evolution, satisfactory from an orthopedic standpoint; ambulation with two crutches indicated.No further information.Additional information received 2/20/2026: invoice related to the surgery performed on (b)(6) 2019 (medical record no.(b)(6) / cic no.(b)(6), including the product reference numbers and the corresponding lot/serial numbers.Implant register and traceability sheet for the revision surgery on (b)(6) 2025 (medical record no.(b)(6) / cic no.(b)(6), including the implant labels for the implanted material.Ref b076.1713.000.00 ceramic head 32mm l 12/14 cone sn: (b)(6).Material: bio ceramic.Suspect device(s): 130-32-51 - nv gxl liner neutral, 32mm id group 1 cups: (b)(6) concomitants: 180-11-48 - nv crown cup clsr hl w/ha 48mm group 1: (b)(6) 164-03-08 - element-stem, collared w/ha, std offset, sz 8: (b)(6) 01-032-03-3294 - universal cup, head, delta, 32mm, -4: (b)(6).

• Brand Name: NOVATION
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24573585
• Report Number: 1038671-2026-00248
• Device Sequence Number: 10474652
• Product Code: MEH
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/09/2026

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: 12/17/2023
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• 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 Age: 65 YR
• Patient Sex: Female