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

Catalog Number	132-28-06
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had a tha, underwent a revision procedure approximately 19 years 5 months post the initial procedure.The patient was revised due to expected wear and reports of dislocation.The head liner was exchanged.It was stated there were no issues with the surgery.The explanted device is not available for return.An x-ray was provided.No further information.
Additional Manufacturer Narrative
D10: 114-01-01 - acumatch p-series, pf, plasma, n/c, sz 1: (b)(6).120-01-48 - acumatch cluster cup porous coated 48mm: (b)(6).120-65-20 - bone screw 6.5mm dia x 20mm long: (b)(6).120-65-25 - bone screw 6.5mm dia x 25mm long: (b)(6).C-28m - ceramic head 28mm +0mm neck: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ACUMATCH 15 DEGREE LINER 28MM SZ F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 24251567
• Report Number: 1038671-2026-00116
• Device Sequence Number: 18219916
• Product Code: LPH
• 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: 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): 02/03/2026

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: 12/15/2007
• Device Catalogue Number: 132-28-06
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2002
• 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; Required Intervention
• Patient Sex: Unknown