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

Catalog Number	136-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 180-01-50 - crown cup, cluster-hole gr.50.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As part of the manufacturer's recall, the patient presented for a follow-up.X-ray and ct scans revealed slight decentration of the prosthetic head and minor osteolysis in the acetabulum, signs of inlay wear.This was verified during an inlay exchange on (b)(6) 2025, to a specially approved, vit e-cured inlay (novation xle +5 mm lateralized liner, group 1, 32 mm id, ref 146-32-51, sn (b)(6)).During the exchange surgery, in addition to the inlay exchange, the firm integrity of the cup was determined, and the cysts in the cup bed were cured and sealed using hydroxyapatite + calcium (cerament bone void filler), as well as the replacement of the prosthetic head.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified, implanted with a lateralized liner and a combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the reported revision due to prosthesis wear and osteolysisis a combination of the risk factors.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6 - investigation coding updated the following sections were corrected: h6 - investigation codes 4118, 3233, 11 no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21923183
• Report Number: 1038671-2025-01920
• Device Sequence Number: 8713627
• Product Code: MEH
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• 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: 2014
• 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): 06/09/2025

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: 06/22/2019
• Device Catalogue Number: 136-32-51
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• 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
• Patient Sex: Female