MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT RO S/O COL SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	164-13-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitants: 170-36-93 - biolox delta femoral head 36mm od, -3.5mm: (b)(6).130-36-52 - nv gxl liner neutral, 36mm id, group 2 cups: (b)(6).164-13-12 - nov element ro s/o col sz 12: (b)(6).180-65-35 - alteon 6.5mm screw, 35mm: (b)(6).101-45-20 - 4.5mm drill bit 20mm: (b)(6).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
As reported, the patient had an initial right tha on (b)(6) 2015.The patient has osteolysis around the acetabular component.The patient's cup was revised to a competitors device.The femoral stem stayed in the patient.There was no reported breakage of a device or surgical delay/prolongation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, g4, h4, h6.Mdr section codes updated/corrected: b, c, d.The most likely underlying cause for the revision reported is prosthesis wear leading to osteolysis and subsequent bone fracture.Meeting one 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) may have been a contributing factor to the liner wear.Prosthesis wear and bone fracture were confirmed from the provided images and radiographs.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h4, h6.Mdr section codes updated/corrected: c.The most likely underlying cause for the revision reported is prosthesis wear leading to osteolysis and subsequent bone fracture.Meeting one 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) may have been a contributing factor to the liner wear.Prosthesis wear and bone fracture were confirmed from the provided images and radiographs.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NOVATION ELEMENT RO S/O COL SZ 12
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21344153
• Report Number: 1038671-2025-00781
• Device Sequence Number: 8959621
• Product Code: JDI
• UDI-Device Identifier: 10885862202703
• UDI-Public: 10885862202703
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2017
• Device Catalogue Number: 164-13-12
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/02/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 07/03/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female