MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 4

Model Number	190-30-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: (cn: 170-32-07, sn: (b)(4)) 36+7 biolox 12/14 head; (cn: 130-32-51, sn: (b)(4)) g1 novation neutral liner.
Event or Problem Description
As reported, approximately 34 months postop the initial left tha, this (b)(6) y/o female patient¿s left hip stem was revised due to loosening.The head was removed and the poly for the cup was removed to check if the cup was well fixed.A new novation liner was implanted and the patient receives an exactech monobloc stem.Patient was last known to be in stable condition following the event.Devices to be returned.Rg pending.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the femoral stem and the bone, which led to aseptic (non-infected) femoral stem loosening.(d11) concomitant devices: (cn: 170-32-07, sn: (b)(6) 36+7 biolox 12/14 head.(cn: 130-32-51, sn: (b)(6) g1 novation neutral liner.

• Brand Name: ALTEON
• Common Device Name: ALT HA S CLR STD SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10676971
• Report Number: 1038671-2020-00570
• Device Sequence Number: 14226470
• Product Code: MEH
• UDI-Device Identifier: 10885862321060
• UDI-Public: 10885862321060
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Expiration Date: 09/05/2022
• Device Model Number: 190-30-04
• Device Catalogue Number: 190-30-04
• Device Lot Number: 85357002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR