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

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 05/20/2022

Event Type  Injury  

Event 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH US, INC.
• MDR Report Key: 14976651
• MDR Text Key: 295724405
• Report Number: MW5110780
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White