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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient previously underwent a left total hip arthroplasty.Over time, the polyethylene component exhibited wear, and the patient experienced associated pain.A revision procedure was performed.The femoral stem was assessed intraoperatively and found to be stable and well-fixed; therefore, it was retained.The patient was revised to an exactech biolox option femoral head and adapter.The acetabular liner was exchanged to a competitor¿s device.The patient was last known to be in stable condition following the event.No further information is available.
Additional Manufacturer Narrative
D10: 120-01-58 - acumatch cluster cup porous coated 58mm (b)(6), 120-65-20 - bone screw 6.5mm dia x 20mm long (b)(6), 142-36-03 - cocr fem head 36mm +3.5 offset 12/14 (b)(6), 160-21-18 - p-fit spline plas ex-off sz 18 (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25071705
• Report Number: 1038671-2026-00531
• Device Sequence Number: 16136256
• Product Code: JDI
• UDI-Device Identifier: 10885862024824
• UDI-Public: 10885862024824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2012
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 04/16/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male