MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR EXT SZ 3

Model Number	190-31-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: (cn: 142-32-00, sn: (b)(4)) cocr femoral head 32mm +0 offset 12/14.(cn: 01-030-40-0232, sn: (b)(4)) alteon xle liner natural g2 32mm.
Event or Problem Description
As reported, approximately i year postop the initial tha, this female patient was revised due to a loose stem.The cocr head was removed after dislocating, the stem was removed, the poly liner was removed to check the cup, a new poly was implanted, and a monobloc stem was re-implanted along with a new head.The patient received a new liner, a 16x245 monobloc, with a new head.The patient appeared to have prior osteoarthritis.Patient was last known to be in stable condition following the event.Devices to be returning.¿.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral stem.The most probable root cause associated with the reported event of "loosening - femoral stem¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: ALTEON
• Common Device Name: ALT HA S CLR EXT SZ 3
• 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: kate jacobson ; 3523782617
• MDR Report Key: 10874660
• Report Number: 1038671-2020-00625
• Device Sequence Number: 19820707
• Product Code: MEH
• UDI-Device Identifier: 10885862320926
• UDI-Public: 10885862320926
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 02/21/2024
• Device Model Number: 190-31-03
• Device Catalogue Number: 190-31-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female