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 03/13/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

It was reported that a patient, initial hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.The patient was revised to a 140-32-51 cc inlay vitamin e, neutral, ø 32, gr.1 6849105.No further information at this time.

Manufacturer Narrative

H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed because the devices were not returned for evaluation and images or radiographs were not provided.

• 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
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19084541
• MDR Text Key: 339877168
• Report Number: 1038671-2024-00784
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention