MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 15DEG LINER 32MM SZ H

Model Number	132-32-28
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 12/14 zirconia head 32mm +0mm neck (cn:148-32-00, sn: 1177606).Pending engineering evaluation.
Event or Problem Description
Index surgery date (b)(6) 2008.Revision due to poly wear.The gxl poly was worn out and osteolysis was visible.The patient was stable was they left the operating room.There was no delay to the surgery.The rep was present at the time of the surgery.The devices will not be returning the device in accordance with hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the result of prosthesis wear which may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient conditions, or a combination of the three, which led to polyethylene wear and osteolysis.However, this cannot be confirmed because the component was not returned for evaluation.Section (d11) concomitant devices: 12/14 zirconia head 32mm +0mm neck (cn:148-32-00, sn: (b)(6)).

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 15DEG LINER 32MM SZ H
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9163106
• Report Number: 1038671-2019-00493
• Device Sequence Number: 2657410
• Product Code: JDI
• UDI-Device Identifier: 10885862023254
• UDI-Public: 10885862023254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 09/05/2010
• Device Model Number: 132-32-28
• Device Catalogue Number: 132-32-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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: 70 YR
• Patient Weight: 70