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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

H3.Investigation results -there is no specific device information provided.The cause of the patient's revision surgery as related to the devices cannot be conclusively determined, insufficient information/reason not reported.These devices are used for treatment not diagnosis.--[date of (b)(6) 2023 used for implant/date of (b)(6) 2023 used for explant].

Event Description

It was reported via legal documentation that a patient had a total left hip arthroplasty on an unknown/unreported date in 2023 and then experienced a surgical revision on an unknown/unreported date in 2023.Implant time is unknown.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device information or device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: HIP LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19201025
• MDR Text Key: 341255275
• Report Number: 1038671-2024-01000
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 04/29/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female