MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; SEE H10

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation ous, that a patient had an initial left hip arthroplasty on (b)(6) 2018.The patient went to an inpatient rehabilitation at the rehabilitation center for orthopedic rehabilitation for an unknown amount of time.Examinations on (b)(6) 2023 showed an immediate need for revision.¿subsequent examinations confirmed the suspicion that the implant from your company showed considerable wear, which is why the attending physicians determined that an immediate revision was necessary.¿ since the end of 2019, the patient has been suffering from increasing back pain after standing and sitting for a long time and recently also with sudden pain symptoms in both hip joints (electric shocks).As of (b)(6) 2023 there has not been a reported surgical revision.There is no specific device information provided.Here is no other patient demographic or medical history available.No additional information is available.

Manufacturer Narrative

H10.H6.Investigation results- the condition reported may have been the result of a combination of risk factors, such as use error, implant positioning, implant size selection, patient factors (fitness for surgery, biomechanics, activity level, and local tissue oxidation potential), and/or surgical approach, which led to prosthesis wear and osteolysis.This could not be confirmed as images/ radiographs were not provided.There is no other information available.

• Brand Name: NOVATION
• Type of Device: SEE H10
• 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: michael crader ; 3523771140
• MDR Report Key: 17670794
• MDR Text Key: 322510025
• Report Number: 1038671-2023-02134
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female