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

Model Number 190-31-03

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2020

Event Type  Injury  

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 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.¿.

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
• Type of Device: 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
• MDR Text Key: 217331773
• Report Number: 1038671-2020-00625
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862320926
• UDI-Public: 10885862320926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female