MAUDE Adverse Event Report: EXACTECH, INC. SCREWS

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Failure of Implant (1924); Swelling (2091); Joint Disorder (2373)

Event Date 03/17/2015

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Patient presented with aseptic humeral loosening.Swelling and redness increased.X-rays showed the humeral and glenoid components were loose.An arthroscopy resection was performed.

Manufacturer Narrative

After further review of additional information received the following sections b4, b5, b6, b7, g3, g4, g7, h2 and h6 have been updated accordingly.In a review of the labeling it is a known complication that a patient's age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of surgical revision to the right shoulder joint devices is most likely due to the patient's underlying conditions, including age.This device is used for treatment, not diagnosis.No information has been provided.A5, a6 and d4.Without serial numbers unable to provide d4.Expiration date & manufactured date.Corrected data: h3: no device evaluation pending, this is a clinical event with no indication of device manufacturing or design issues.

Event Description

Reported from a clinical study database.Right shoulder.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00328, 1038671-2017-00329, 1038671-2017-00330, 1038671-2017-00331 and 1038671-2017-00332.

• Brand Name: SCREWS
• Type of Device: SCREWS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6612323
• MDR Text Key: 76673356
• Report Number: 1038671-2017-00333
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 57