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

Catalog Number	132-28-06
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: 114-11-02 - acum p-series por coat collarless size 2: (b)(6), 120-01-50 - acum cluster cup porous coated 50mm: (b)(6), 120-65-15 - bone scr 6.5mm dia x 15mm long: (b)(6), c-28m - ceramic head 28mm +0mm neck: (b)(6).
Event or Problem Description
As reported, approximately 20 years and 6 months post the initial total hip replacement, the patient was revised due to pain and wear.The patient was converted to a competitor cup and dual mobility liner.A new exactech head was placed.There were no issues with the surgery.No further information provided.

• Brand Name: ACUMATCH 15 DEGREE LINER 28MM SZ F
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23083103
• Report Number: 1038671-2025-02939
• Device Sequence Number: 9812331
• Product Code: JDI
• UDI-Device Identifier: 10885862023018
• UDI-Public: 10885862023018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2025
• 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): 09/18/2025

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: 12/15/2009
• Device Catalogue Number: 132-28-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 12/17/2004
• 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 Sex: Unknown