MAUDE Adverse Event Report: EXACTECH, INC. ALTEON 6.5MM SCREW, 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	180-65-30
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right hip replacement surgery on (b)(6) 2018.They underwent right hip revision surgery on (b)(6) 2023, approximately 4 years 8 months after their initial implantation.The patient claims to have suffered from extreme pain, limping, instability and a revision surgery as a result of this device.Patient experienced prothesis wear, loosening, synovitis, failure of implant, osteolysis, joint laxity and pain.There is no other patient demographic or medical history available.Per the revision operative notes, "the stem was well fixed.I [surgeon] used a bone tamp and removed the ceramic head.The trunnion was in good condition.¿ i used a screwdriver and removed the acetabular liner and could see significant wear superolaterally.I used a screwdriver and removed the screws in the acetabulum.These screws no longer had purchase.There was osteolysis around the screws and they were loose.¿ the cup was stable and well fixed." based on the event description, the wear on the tibial insert appears to be uneven.This could indicate instability and/or relative component malposition.Additionally, the polyethylene wear debris may have contributed to the osteolysis, which in turn may have led to loss of bony purchase of the screws.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Report number: 1038671-2023-02087, 1038671-2025-00073 d10concomitants: 170-40-00 - biolox delta femoral 40mm od, +0mm 5314873 180-65-25 - alteon 6.5mm screw, 25mm 5403711 186-01-58 - integrip cc, cluster 58mm, g3 5396926 188-00-11 - wedge plasma s/o sz 11 4597715 130-40-53 - nv gxl liner neutral, 40mm id, group 3 cups 4191250 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02087, 1038671-2025-00073 based on the available information, the patient involved in incident meets the following risk criteria for early prosthesis wear: combination of largest available femoral head and/or thinnest available liner was used, implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision reported is a combination of 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).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALTEON 6.5MM SCREW, 30MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21078773
• Report Number: 1038671-2025-00074
• Device Sequence Number: 18253710
• Product Code: LPH
• UDI-Device Identifier: 10885862272669
• UDI-Public: 10885862272669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: 02/05/2022
• Device Catalogue Number: 180-65-30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 02/06/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male