MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR EXT SZ 7

Model Number 190-31-07

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

Patient Problem Failure of Implant (1924)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

The evaluation is pending.

Event Description

As reported, approximately 3 years after the initial tha, the (b)(6) y/o male patient¿s right hip dislocated and was revised due to loosening of the stem.The femoral head was removed.The stem was checked and found to be loose.The stem was removed.The liner was removed, and the cup was checked.It was found to be well fixed.A new liner was implanted.The patient also received a new stem and head.Patient was last known to be in stable condition following the event.The devices were not saved by the facility.Concomitant devices: (cn: 138-36-52, sn: (b)(4)) - nv gxl lnr, 10 deg face, 36mm id, grp 2 cup.(cn: 170-36-00, sn: (b)(4)) - biolox delta femoral head 36mm od, +0mm.

Manufacturer Narrative

Section h10: (h3) the evaluation of the of the reported event 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.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: ALTEON
• Type of Device: ALT HA S CLR EXT SZ 7
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11314297
• MDR Text Key: 240340059
• Report Number: 1038671-2021-00032
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862320964
• UDI-Public: 10885862320964
• Combination Product (y/n): N
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 190-31-07
• Device Catalogue Number: 190-31-07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR