MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; SEE H10

Model Number	WEDGE PLASMA S/O SZ 5
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information found during the investigation of a legal complaint; that the 58-year-old female patient underwent open reduction internal fixation of right femur for periprosthetic fracture on (b)(6) 2017 , approximately 3 months post initial implant procedure.Surgeon¿s preoperative diagnosis was confirmed during surgical revision.No evidence of infection per the revision operative report.Routine cultures were made.Gram stains were clear.Surgeon noted, "the patient was awakened and transferred to the recovery room in stable condition having tolerated the procedure well." no device return is anticipated due to this being a legal case.No images or x-rays provided.No other patient or medical information is provided.No further information.
Additional Manufacturer Narrative
Prosthesis, hip, semi-constrained, metal polymer, cemented.Concomitant medical products:¿ (b)(4).130-32-51 nv gxl liner neutral, 32mm id group 1 cups serial number (b)(4).Is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(4).170-32-03 - biolox delta femoral head 32mm od, +3.5mm, (b)(4).180-01-48 - nv crown cup clstr hole 48mm group 1, (b)(4).180-65-20 - alteon 6.5mm screw, 20mm, (b)(4).180-65-20 - alteon 6.5mm screw, 20mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information: a2, b6, b7, g4 h6.Investigation codes h6.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause the periprosthetic fracture and revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Devices were not returned and there were no photos or other images provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6: clinical code, medical device problem code.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALTEON
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16549548
• Report Number: 1038671-2023-00446
• Device Sequence Number: 6042724
• Product Code: JDI
• UDI-Device Identifier: 10885862250773
• UDI-Public: 10885862250773
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K140674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: WEDGE PLASMA S/O SZ 5
• Device Catalogue Number: 188-00-05
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/23/2026
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/06/2023; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female