MAUDE Adverse Event Report: EXACTECH, INC. HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

It was reported that a patient, who had an initial implant on an unknown date, underwent a revision procedure on (b)(6) 2024, for reasons unknown and was implanted with a 6973110 140-32-51 cc inlay vitamin e, neutral, ø 32, gr.1.No additional information.

Manufacturer Narrative

H3: according to the information provided, the patient underwent a total hip replacement surgery on an unknown date.The device included a novation gxl liner, but specific product information was not provided.The patient was revised in (b)(6) 2024 due to prosthesis wear.The most likely cause for the reported revision due to prosthesis wear is a combination of the risk factors specified in an hhe which include use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

Manufacturer Narrative

H6: corrected health effect - clinical code.

• Brand Name: HIP COMPONENTS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19095353
• MDR Text Key: 339998856
• Report Number: 1038671-2024-00821
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2024

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: 04/05/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 07/15/2024
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention