MAUDE Adverse Event Report: EXACTECH, INC EXACTECH FEMORAL HEAD, 12/14, COBALT CHROMIUM, 28MM OD

Catalog Number 142-28-03

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision of hip components due to dislocation.Patient dislocated and an er doctor tried to reduce and pulled the bipolar component off of the 28mm head.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of the mainpulation performed, which led to disassociation of the bipolar head and the femoral head.

Event Description

Index surgery: (b)(6) 2015.Revision of hip components due to dislocation.Patient dislocated and an er doctor tried to reduce and pulled the bipolar component off of the 28mm head.

• Brand Name: EXACTECH FEMORAL HEAD, 12/14, COBALT CHROMIUM, 28MM OD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5187656
• MDR Text Key: 29816475
• Report Number: 1038671-2015-00629
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 142-28-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 79 YR