MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR EXT SZ 6

Model Number	190-31-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 41 months postop this (b)(6) male patient¿s left hip the patient was revised due to loosening.Pt has history of osteoarthritis.The head was removed, the stem was removed, and the poly liner was removed to check the cup.The cup was well fixed, the patient received a new liner, a new monobloc stem, and a new biolox head.The patient received a new 40mm liner lipped insert, a 19x245 monobloc stem with a 40 +7 biolox head.Devices are returning.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) the evaluation of the of the reported event noted that revision was likely the result of an insufficient bond between the femoral stem and the bone, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) femoral stem loosening.

• Brand Name: ALTEON
• Common Device Name: ALT HA S CLR EXT SZ 6
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11006311
• Report Number: 1038671-2020-00649
• Device Sequence Number: 3822952
• Product Code: MEH
• UDI-Device Identifier: 10885862320957
• UDI-Public: 10885862320957
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: Health Professional
• Device Model Number: 190-31-06
• Device Catalogue Number: 190-31-06
• Device Lot Number: 78454043
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86