MAUDE Adverse Event Report: EXACTECH US, INC. EXACTECH CONNEXION GXL ACETABULAR LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had 2012 right total hip replacement with exactech connexion gxl acetabular liner with early wear, acetabular osteolysis leading to periprosthetic fracture requiring complex revision r tha (right total hip arthroplasty).Fda safety report id # (b)(4).

• Brand Name: EXACTECH CONNEXION GXL ACETABULAR LINER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH US, INC.
• MDR Report Key: 14976651
• Report Number: MW5110780
• Device Sequence Number: 16894145
• Product Code: LZO
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White