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

Model Number	02-012-49-2009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ACUMATCH CLUSTER CUP POROUS COATED 56MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10837206
• Report Number: 1038671-2020-00610
• Device Sequence Number: 3349066
• Product Code: JDI
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR