MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Insufficient Information (4580)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, osteolysis, loosening, infection, fracture, instability/dislocation, leg length discrepancy, and/or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient who had a hip implanted, underwent a revision procedure.Reason unknown.The liner was revised.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, osteolysis, loosening, infection, fracture, instability/dislocation, leg length discrepancy, and/or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b5, d4, d6a, d6b.D10: 180-01-52 - crown cup, cluster-hole gr.52: sn #(b)(6).H4, h6, h11.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
Due to recurrent symptoms, the patient presented for a follow-up examination.X-ray and ct scans revealed significant decentering of the prosthetic head and unusually large osteolytic lesions in the acetabulum, indicative of inlay wear.This was confirmed during an inlay replacement procedure, using a specially approved vitamin e-hardened inlay.The procedure involved verification of the components.During the revision surgery, in addition to replacing the inlay, the integrity of the acetabular cup was confirmed, the cysts in the acetabular socket were curetted and filled with hydroxylapatite + calcium (cerement bone void filler), and the prosthetic head was replaced.No further information.This is 1 of 2 events for this patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified: implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to prosthesis wear and osteolysis is a combination of the risk factors specified.However, this cannot be confirmed because the devices were not available for evaluation, and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NOVATION
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 22789833
• Report Number: 1038671-2025-02740
• Device Sequence Number: 15908367
• Product Code: JDI
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 02/15/2020
• Device Catalogue Number: 136-32-52
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 11/07/2025; 01/21/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/05/2025; 12/05/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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 Sex: Female