MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALTEON HA S NOCLR STD SZ 5

Model Number	190-20-05
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: (cn: 170-36-00, sn: (b)(4)) - biolox delta femoral head 36mm od, +0mm, (cn: 01-030-01-0450, sn: (b)(4)) - alt cup clstr g4 sz 50, (cn: 180-65-25, sn: (b)(4)) - alteon 6.5mm screw, 25mm, (cn: 180-65-30, sn: (b)(4)) - alteon 6.5mm screw, 30mm, (cn: 01-030-40-0436, sn: (b)(4)) - alt xle lnr ntrl g4 36.
Event or Problem Description
As reported, a right primary anterior total hip was performed on a (b)(6) female patient.Approximately 11 days postop, during physical therapy, the patient experienced sharp pain and was admitted to the hospital, the stem has subsided, and the femur possibly has fractured.Revision of the femur is scheduled for next week.No further information has been received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was most likely the result of a bone fracture which subsequently led to subsidence of the femoral component.The bone fracture may have been secondary to poor bone quality, an intra-operative fracture that went unnoticed, or a combination of the two, but cannot be conclusively determined from the information provided.The components were only implanted for 11 days before the stem subsided and patient was subsequently revised.(d11) concomitant device: (cn: 170-36-00, sn: (b)(6) - biolox delta femoral head 36mm od, +0mm (cn: 01-030-01-0450, sn: (b)(6) - alt cup clstr g4 sz 50 (cn: 180-65-25, sn: (b)(6) - alteon 6.5mm screw, 25mm (cn: 180-65-30, sn: (b)(6) - alteon 6.5mm screw, 30mm (cn: 01-030-40-0436, sn: (b)(6) - alt xle lnr ntrl g4 36 no information provided in the following section(s): a4 a5, b6 the following section(s) have additional info; g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: ALTEON
• Common Device Name: ALTEON HA S NOCLR STD SZ 5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10131330
• Report Number: 1038671-2020-00299
• Device Sequence Number: 3407123
• Product Code: MEH
• UDI-Device Identifier: 10885862321824
• UDI-Public: 10885862321824
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 01/22/2024
• Device Model Number: 190-20-05
• Device Catalogue Number: 190-20-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR