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

Catalog Number	130-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In 2015, the patient had a hip prosthesis cup from exactech implanted.As part of the manufacturer's recall, the patient came in for a check-up.The x-ray and ct scans showed a clear decentration of the prosthesis head and unusually large osteolyses in the acetabulum as signs of inlay wear.This was verified when the inlay was changed on (b)(6) 2024 to a vit e-hardened, specially approved inlay (novation xle, neutral liner, group 3, 36 mm i.D., ref: 140-36-53, sn: (b)(6).As part of the replacement operation, in addition to the inlay exchange, the firm cup integrity was determined, as well as the curettage and filling of the cysts in the cup bed using hydroxyapatite + calcium (cerament bone void filler) and the prosthesis head was changed.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3 - the devices were not returned for analysis.No images, radiographs, or patient information was provided.The hhe noted, there is evidence that a moderately higher risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the increased trend in wear/osteolysis.Patients with increased risk tend to present with signs for prosthesis wear and subsequent particle-induced osteolysis within the first 5 years after the index arthroplasty and have the following characteristics: significant edge loading of the femoral head on the acetabular liner, patients implanted with a lateralized liner, patients in whom the largest available femoral head and/or thinnest available acetabular liner was used, and patients implanted with a component having a shelf age of greater than 2 years.Those patients having a combination of risk factors will have the highest risk for early wear and lysis.According to the information provided, the patient underwent a total hip replacement surgery.The device included a novation gxl liner.The patient was revised due to prosthesis wear.However, this cannot be confirmed since the device was not returned for evaluation, and images or radiographs were not provided.The most likely cause for the reported revision due to prosthesis wear is a combination of the risk factors specified.However, this cannot be confirmed with the information that was provided.H6 - clinical, component, investigation codes added.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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20403104
• Report Number: 1038671-2024-03877
• Device Sequence Number: 6518240
• Product Code: MEH
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 10/22/2019
• Device Catalogue Number: 130-32-53
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 180-01-58 - CROWN CUP, CLUSTER-HOLE GR.58, (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male