MAUDE Adverse Event Report: EXACTECH, INC. ALTEON 6.5MM SCREW, 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	180-65-35
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 170-36-03 - biolox delta femoral head 36mm od, +3.5mm; (b)(6), 180-01-56 - nv crown cup clstr hole 56mm group 3; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 188-01-11 - wedge plasma x/o sz 11.
Event or Problem Description
Legal case ¿ usa: related (b)(4) rh rev.As reported via legal documentation the patient had a left hip replacement on (b)(6) 2017.Approximately 6 years and 5 months after the initial procedure the patient had a left hip revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023: diagnosis: failed left total hip replacement.The abductor muscle belly was retracted, aspirated through the hip capsule and obtained 20 ml of serosanguineous fluid that was sent for cultures.There was an obvious adverse local tissue reaction with a lot of brown villonodular synovitis throughout the wound.A thorough synovectomy as the case proceeded and sent tissue for culture and also tissue for pathology.The hip was rotated and tucked the trunnion posteriorly and exposed the acetabulum.Debridement of the adverse tissue and the synovitis was completed.The rim had poly wear.There was osteolysis around the screw holes, greater on the posterior side.Ebi initial surgery attached.Historical record and smartsolve searched for sn/patient name with no results.As directed by qa management: this legal complaint for polyethylene issues occurred in the us.The event did not occur in, nor is it reportable for australia, brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.(b)(6), 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups: serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k070479.Recall: z-1729-2022.Concomitants: (b)(6), 170-36-03 - biolox delta femoral head 36mm od, +3.5mm; (b)(6), 180-01-56 - nv crown cup clstr hole 56mm group 3; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 180-65-35 - alteon 6.5mm screw, 35mm; (b)(6), 188-01-11 - wedge plasma x/o sz 11.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement.Approximately 6 years and 5 months after the initial procedure the patient had a left hip revision.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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, 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20621912
• Report Number: 1038671-2024-04268
• Device Sequence Number: 7534297
• Product Code: JWH
• UDI-Device Identifier: 10885862272676
• UDI-Public: 10885862272676
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 01/23/2022
• Device Catalogue Number: 180-65-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 01/24/2017
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown