MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH ACETABLULAR SHELL; ACETABULAR SHELL

Device Problems Break (1069); Disconnection (1171); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The locking ring disengaged and part of the poly had broken at the rim.The shell was reported to be poorly positioned and extremely anteverted.Surgeon removed the liner and shell and reimplanted a new shell.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

• Brand Name: EXACTECH ACETABLULAR SHELL
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cutbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4287631
• MDR Text Key: 5231725
• Report Number: 1038671-2014-00550
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2014
• 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