MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH CLUSTER CUP POROUS COATED 62MM

Model Number	120-01-62
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: 28mm +5 femoral head (cn: 100-28-05, (b)(4)); 28mm 15 deg liner size j (cn:132-28-09, sn: (b)(4)); bone screw (cn: 120-65-40, sn: (b)(4)); bone screw (cn: 120-65-20, sn: (b)(4).
Event or Problem Description
As reported, this male patient was initial implanted with exactech devices on an unknown date, unknown facility and unknown surgeon.A revision surgery performed on (b)(6) 2001.No other information available on the revision except that exactech devices were implanted.The current event for this (b)(6) y/o male patient is the acetabular shell needed revision due to migrating into a vertical position.The cup/liner and two screws were removed.Acetabulum was reamed and competitor devices was implanted along with exactech cocr head 28+5.The hip was found to be stable and wound was closed.Patient was last known to be in stable condition following the event.Devices will not be returned due to hospital policy.Photo of explanted device was provided.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported may have been the result of aseptic loosening after being implanted for over 18 years, which led to the reported migration of the acetabular cup.However, this cannot be confirmed due to limited information and the devices not being available for evaluation.(d11) concomitant device(s): cemented finned tib.Tra sz 3f/3t (cn: 200-04-33, sn: (b)(6).
Event or Problem Description
As reported, this male patient was initial implanted with exactech devices on an unknown date, unknown facility and unknown surgeon.A revision surgery performed on (b)(6) 2001.No other information available on the revision except that exactech devices were implanted.The current event for this 70 y/o male patient is the acetabular shell needed revision due to migrating into a vertical position.The cup/liner and two screws were removed.Acetabulum was reamed and competitor devices was implanted along with exactech cocr head 28+5.The hip was found to be stable and wound was closed.Patient was last known to be in stable condition following the event.Devices will not be returned due to hospital policy.Photo of explanted device was provided.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH CLUSTER CUP POROUS COATED 62MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9758232
• Report Number: 1038671-2020-00221
• Device Sequence Number: 19446912
• Product Code: JDI
• UDI-Device Identifier: 10885862019783
• UDI-Public: 10885862019783
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 01/30/2010
• Device Model Number: 120-01-62
• Device Catalogue Number: 120-01-62
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention