MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH CLUSTER CUP POROUS COATED 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	120-01-44
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 15 years 8 months post op initial left tha, this 51 y/o female patient was revised.Head wore through the liner and the cup.Cup needed to be removed.Patient had a hip done in 2008 with m series steam nd acumatch cup.Used competitors device revision cup and exactech head.Patient was last know to be in stable condition following the event.Unable to obtain photos or x-rays.Product not returning - hospital won't release.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 120-01-44 - acumatch cluster cup porous coated.44mm.

• Brand Name: ACUMATCH CLUSTER CUP POROUS COATED 44MM
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20725533
• Report Number: 1038671-2024-04430
• Device Sequence Number: 8395888
• Product Code: JDI
• UDI-Device Identifier: 10885862019691
• UDI-Public: 10885862019691
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2023
• 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): 11/19/2024

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 Catalogue Number: 120-01-44
• 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: 08/22/2023
• Initial Report FDA Received Date: 11/19/2024
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female