MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH CLUSTER CUP POROUS COATED 56MM

Model Number 02-012-49-2009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: (cn: 132-36-28, sn: (b)(4)) acumatch gxl 15 deg liner 36mm sz h.(cn: 142-36-10, sn: (b)(4)) cocr fem head 36mm +10 offset 12/14.(cn: 120-65-50, sn: (b)(4)) alteon screw 6.5mm x 50mm.

Event Description

Approximately 16 months this (b)(6) y/o male patient fell, and the cup was knocked loose.During a revision, the entire right acetabular side, and the femoral head, were explanted, however only the femoral head was replaced with an exactech head.All other explanted components were replaced with competitor¿s products.Devices not returning as the hospital threw away.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the evaluation of the of the revision reported based upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.This cause of the reported event is not known at this time as no reason for the revision was reported.(d11) concomitant device: (cn: 132-36-28, sn: (b)(6) acumatch gxl 15 deg liner 36mm sz h.(cn: 142-36-10, sn: (b)(6) cocr fem head 36mm +10 offset 12/14.(cn: 120-65-50, sn: (b)(6) alteon screw 6.5mm x 50mm.

• Brand Name: ACUMATCH A SERIES
• Type of Device: ACUMATCH CLUSTER CUP POROUS COATED 56MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10837206
• MDR Text Key: 216160032
• Report Number: 1038671-2020-00610
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (y/n): N
• PMA/PMN Number: K993082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2013
• Device Model Number: 02-012-49-2009
• Device Catalogue Number: 120-01-56
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR