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

Model Number 190-31-06

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

Patient Problem Failure of Implant (1924)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event 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.

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
• Type of Device: ALT HA S CLR EXT SZ 6
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11006311
• MDR Text Key: 221537330
• Report Number: 1038671-2020-00649
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862320957
• UDI-Public: 10885862320957
• Combination Product (y/n): N
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190-31-06
• Device Catalogue Number: 190-31-06
• Device Lot Number: 78454043
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86