MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH CLUSTER CUP POROUS COATED 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	120-01-54
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 118-01-02 - p-series pf plasma collarless sz 2 12/14, (b)(6), 148-28-00 - 12/14 zirconia head 28mm +0mm neck, (b)(6), 120-65-25 - bone screw 6.5mm dia x 25mm long, (b)(6), 120-65-25 - bone screw 6.5mm dia x 25mm long, (b)(6), 120-65-30 - bone screw 6.5mm dia x 30mm long, (b)(6), 132-28-27 - acumatch gxl 15deg liner 28mm sz g.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 review of complaint history determined that no further action is required as no trends were identified.The revision reported may have been the result of prosthesis wear, osteolysis, periprosthetic fracture, and acetabular cup loosening after being implanted for over 12.75 years.The prosthesis wear may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) acetabular loosening may have been the result of an insufficient bond between the acetabular cup and the bone.Additional contributing factors to the reported failures may have been the result of a combination of the risk factors, including but not limited to, being implanted with a component having a shelf age of greater than 2 years.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this 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 via legal that 13 years post op the initial right tha, this female patient was revised due to severe osteolysis, poly wear and periprosthetic fracture.Patient was having pain and x-ray revealed actebular poly wear and osteolysis.Surgeon performed a revision of the right acetabular components and femoral head.No additional information available.

• Brand Name: ACUMATCH CLUSTER CUP POROUS COATED 54MM
• 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 FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 25165314
• Report Number: 1038671-2026-00600
• Device Sequence Number: 18797606
• Product Code: LPH
• UDI-Device Identifier: 10885862019745
• UDI-Public: 10885862019745
• 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: 2008
• Device Explanted Year: 2021
• 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): 05/13/2026

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: 02/09/2013
• Device Catalogue Number: 120-01-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 02/11/2008
• 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: Required Intervention
• Patient Sex: Female