MAUDE Adverse Event Report: EXACTECH, INC. ALTEON 6.5MM SCREW, 20MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	180-65-20
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Aseptic loosening (4883)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total hip replacement on the right side.Subsequently, the patient experienced pain, discomfort, osteolysis and aseptic loosening secondary to prosthesis wear.As a result, approximately four years post-surgery, the patient underwent a revision.It was noted the patient had dense scar tissue.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 3 of 3 for this event/patient.
Additional Manufacturer Narrative
D10: 136-36-53 - nv gxl lnr, +5lat, 36mm g3-56/58mm cups: sn# (b)(6) 180-65-20 - alteon 6.5mm screw, 20mm: sn# (b)(6), 186-01-56 - integrip cc, cluster 56mm, g3: sn# (b)(6), 190-30-05 - alt ha s clr std sz 5: sn# (b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm: sn# (b)(6).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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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, 20MM
• 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 ct; gainesville 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24732664
• Report Number: 1038671-2026-00353
• Device Sequence Number: 18690131
• Product Code: LPH
• UDI-Device Identifier: 10885862272645
• UDI-Public: 10885862272645
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K141797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 12/13/2023
• Device Catalogue Number: 180-65-20
• 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: 10/28/2024
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 12/20/2018
• 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 Age: 65 YR
• Patient Sex: Male