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

Model Number	ACUMATCH GXL 15DEG LINER 36MM SZ J
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, who had an initial hip implanted, date unknown, and had a head liner revised on (b)(6) 2020, is probably going to have to be revised again for poly wear particulate issues.No further information.On (b)(6) 2020 head liner revision reported under mdr #1038671-2022-01155.
Additional Manufacturer Narrative
The patient involved was reportedly experiencing prosthesis wear, following the index surgery.However, the patient was not yet revised, and no images or radiographs were provided.The prosthesis wear reported may have been due to a combination of risk factors specified including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
Manufacturer narrative updated: the prosthesis wear reported may have been due to a combination of risk factors including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d6a/d6b, g1, h1, h6: clinical code.The prosthesis wear reported may have been due to 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) including but not limited to use error, implant positioning, and patient factors.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.
Event or Problem Description
It was reported that a male patient, who had an initial hip implanted, date unknown, and had a head liner revised and has stated is probably going to have to be revised again for poly wear particulate issues.No further information.

• Brand Name: ACUMATCH GXL 15DEG LINER 36MM SZ J
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18932377
• Report Number: 1038671-2024-00563
• Device Sequence Number: 18482970
• Product Code: JDI
• UDI-Device Identifier: 10885862023407
• UDI-Public: 10885862023407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Model Number: ACUMATCH GXL 15DEG LINER 36MM SZ J
• Device Catalogue Number: 132-36-29
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 09/30/2024; 02/13/2026
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/28/2024; 10/01/2024; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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: 100-36-00 - 36MM +0MM FEMORAL HEAD 5834507
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male