MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH CLUSTER CUP POROUS COATED 60MM

Model Number	120-01-60
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: 36mm femoral head (cn: 142-36-93, sn: (b)(4)); 60mm acetabular shell (cn: 120-01-60, sn: (b)(4)); 36mm acetabular liner size j (cn: 132-36-29, sn: (b)(4)); bone screw (cn: 120-65-35, sn: (b)(4)); bone screw (cn: 120-65-35, sn: (b)(4)).
Event or Problem Description
As reported, the original left total hip arthroplasty on this (b)(6) y/o male patient was performed on (b)(6) 2007.This patient was revised due to the acetabular shell appears to be loose.The surgeon opened the patient and dissected down to the joint space.He dislocated the hip and removed the femoral head, then proceeded to remove the acetabular shell, liner, and two screws.A competitor shell and liner was placed.He replaced the previous femoral head with the same size (36mm -3.5 offset).The surgeon was happy with these implants and closed the patient.Patient was last known to be in stable condition following the event.Devices will not be returned due to hospital policy.
Event or Problem Description
As reported, the original left total hip arthroplasty on this 76 y/o male patient was performed on (b)(6) 2007.This patient was revised due to the acetabular shell appears to be loose.The surgeon opened the patient and dissected down to the joint space.He dislocated the hip and removed the femoral head, then proceeded to remove the acetabular shell, liner, and two screws.A competitor shell and liner was placed.He replaced the previous femoral head with the same size (36mm -3.5 offset).The surgeon was happy with these implants and closed the patient.Patient was last known to be in stable condition following the event.Devices will not be returned due to hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) cup loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation (d11) concomitant devices: - 36mm femoral head (cn: 142-36-93, sn: (b)(6).- 60mm acetabular shell (cn: 120-01-60, sn: (b)(6).- 36mm acetabular liner size j (cn: 132-36-29, sn: (b)(6).- bone screw (cn: 120-65-35, sn: (b)(6).- bone screw (cn: 120-65-35, sn: (b)(6).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH CLUSTER CUP POROUS COATED 60MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9699795
• Report Number: 1038671-2020-00066
• Device Sequence Number: 14059053
• Product Code: JDI
• UDI-Device Identifier: 10885862019776
• UDI-Public: 10885862019776
• 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: 2007
• 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: 12/08/2010
• Device Model Number: 120-01-60
• Device Catalogue Number: 120-01-60
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR