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

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/27/2008

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.

Event Description

It was reported via legal documentation - implant date is unknown.Operative report of (b)(6) 2008- revision right hip for osteolysis and polyethylene wear.The female patient ¿ ¿previously underwent total hip arthroplasty 10 years ago.She has had gradual wear of polyethylene and has developed osteolysis in her acetabulum.She has increasing symptoms of pain in her hip.This is believed to be due to synovitis in the hip.She presents for revision right total hip arthroplasty.¿ revised to exactech devices.The patient was taken to the recovery room in stable condition.There is no other information available.

Manufacturer Narrative

H10.Updated/additional information ¿ d1.G1.G2.G4.H6.The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: FEMORAL COMPONENT
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 18499274
• MDR Text Key: 332724810
• Report Number: 1038671-2024-00087
• Device Sequence Number: 1
• Product Code: JDI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/16/2024
• 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 Age: 52 YR
• Patient Sex: Female