MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	138-36-28
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years post op initial right tka, this 78 y/o male patient was revised.Hip instability caused dislocation.Constrained cup was needed, to accommodate, an exactech head was matched with competitors cup.Acetabular side was fully revised to different manufacturer.Patient was last known to be in stable condition following the event.No other medical/patient information provided.Unable to obtain images or x-rays.Product not returning due to hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4353085, 100-36-10, 36mm +10mm femoral head.0174259, 120-01-58, 58mm acumatch shell.0259514, 120-65-25, bone screw, 25mm.0262851, 120-65-25, bone screw, 25mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The cause of the patient¿s dislocation/instability and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue tension, implant positioning, and/or implant selection.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Dislocation and subluxation are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17549580
• Report Number: 1038671-2023-01952
• Device Sequence Number: 6665426
• Product Code: JDI
• UDI-Device Identifier: 10885862024824
• UDI-Public: 10885862024824
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 01/06/2019
• Device Catalogue Number: 138-36-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1728-2022
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male