MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 15DEG LINER 36MM SZ H

Model Number	132-36-28
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: cocr fem head 36mm +0 (cn: 142-36-00, sn: (b)(4).Size h acumatch acetabular 15 degree liner (cn: 132-36-28, (b)(4).Bone screw (cn: 125-65-40, sn: (b)(4).
Event or Problem Description
As reported, approximately 14 years postop the initial left tha this male patient presented complaining of pain.The left hip acetabular components were found to be malpositioned and worn.A revision was completed.The femoral stem was left implanted, the femoral head was removed and replaced.All components on the acetabular side were replaced with competitor devices due to malpositioning and wear.This patient had the femoral components in the left hip revised 1 year ago.The femoral side was removed and replaced with competitor devices, but acetabular side remained implanted, just swapped out the poly liner.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 in the revision reported was likely the result of a combination of prosthesis wear and malalignment of the acetabular component.The subsequent malalignment of the acetabular component may have led to an increase in prosthesis wear due to edge loading and the subsequent prosthesis wear may have contributed to particle-induced osteolysis and possible migration of the acetabular cup.However, the contributions of acetabular cup positioning and prosthesis wear to the sequence of events cannot be determined from the provided information and the devices were not available for evaluation.(d11) concomitant devices: - cocr fem head 36mm +0 (cn: 142-36-00, sn: (b)(6) - size h acumatch acetabular 15 degree liner (cn: 132-36-28, sn: (b)(6) - bone screw (cn: 125-65-40, sn: (b)(6) no information provided in the following section(s): a2, a4, a5, and b6.The following section(s) have additional info; g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 15DEG LINER 36MM SZ H
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10220601
• Report Number: 1038671-2020-00329
• Device Sequence Number: 11571524
• Product Code: JDI
• UDI-Device Identifier: 10885862023391
• UDI-Public: 10885862023391
• Combination Product (Y/N): N
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 05/22/2010
• Device Model Number: 132-36-28
• Device Catalogue Number: 132-36-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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