MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 28MM SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-28-25
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 1596130 148-28-10 - 12/14 zirconia head 28mm +10mm neck.1692101 118-00-00 - p-ser 12/14 pf plasma collared sz 0.1867082 120-01-46 - acumatch cluster cup porous coated 46mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 67 yo female patient, initial right hip implanted on march 7, 2011, underwent a revision procedure on (b)(6) 2023 , approximately 12 years 3 months post the initial procedure.The patient was seen by the surgeon due to slight hip pain.The surgeon scheduled surgery to switch out the liner and head and to check the stability of the stem and cup.During surgery, the surgeon removed the head and then proceeded to remove the liner.He checked the stability of the cup which seemed well fixed.He decided to replace the liner with a new accumatch sz e liner 15 degree vit e liner.The surgeon inspected the stem.The stem seemed to be well fixed, and the neck and trunnion seemed to be in good shape.He then implanted a 28 +10 cobalt chrome head and reduced the hip.The leg length looked good, and the patient was stable.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No device returns anticipated.The hospital is keeping the devices.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g3, h6, h11.Mdr section codes updated/corrected: a, b, c, d.The most likely underlying cause for the revision is a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) and being implanted for more than 10 years.However, this cannot be confirmed from the reported information, and the devices were not available for evaluation.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 15DEG LINER 28MM SZ E
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17333632
• Report Number: 1038671-2023-01677
• Device Sequence Number: 20485021
• Product Code: JDI
• UDI-Device Identifier: 10885862023070
• UDI-Public: 10885862023070
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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): 09/25/2025

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: 06/10/2014
• Device Catalogue Number: 132-28-25
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female