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

Catalog Number	132-36-28
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 120-01-56 ¿ acumatch cluster cup porous coated 56mm.148-36-00 ¿ 12/14 zirconia head 36mm rep by 170-36-00 160-31-15 ¿ pf spline plasma w/ha ext offset sz 15.H7: z-2122-2021.
Event or Problem Description
As reported, the patient had an initial tha on (b)(6) 2006.The patient is pending revision; reason unknown and date unknown.No further information has been provided.
Additional Manufacturer Narrative
H3: the most likely reason for the revision reported is prosthesis wear over the course of 17 years of implantation.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, h6 clinical code, impact code, problem code, and component code.This follow-up report is being submitted to relay additional information.The following sections were updated: d4, d6a, g4, h4.

• Brand Name: ACUMATCH GXL 15DEG 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18611302
• Report Number: 1038671-2024-00138
• Device Sequence Number: 7668299
• Product Code: JDI
• UDI-Device Identifier: 10885862023391
• UDI-Public: 10885862023391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 10/26/2007
• Device Catalogue Number: 132-36-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2005
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown