MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 8

Model Number	190-30-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: novation ehxl natural liner g3 36mm; (cn: 140-36-53, sn: (b)(4)).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(4)).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(4)).
Event or Problem Description
As reported, approximately 11 months postop the initial left tha.This (b)(6) y/o male with a history of osteoarthritis, was revised.The patient received a new xle 40mm lipped liner, a 19x245 monobloc and a 40mm +10 head.Devices not returning.The patient requested the implants.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic loosening of the femoral stem.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device: novation ehxl natural liner g3 36mm (cn: 140-36-53, sn: (b)(6).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(6).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(6).

• Brand Name: ALTEON
• Common Device Name: ALT HA S CLR STD SZ 8
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11060999
• Report Number: 1038671-2020-00663
• Device Sequence Number: 1265500
• Product Code: MEH
• UDI-Device Identifier: 10885862321107
• UDI-Public: 10885862321107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: No Information
• Device Expiration Date: 09/04/2023
• Device Model Number: 190-30-08
• Device Catalogue Number: 190-30-08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR