MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL

Catalog Number 254400519

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

Dr used the balanced sizer from the attune total knee system. The instrument binded up and would not allow him to match his flexion gap to his extension gap. The instrument just would not wind up and was too tight to achieve the minimum poly thickness of 5mm. It did not have an adverse impact on the patient as he used the measured sizer to size the femur and set rotation. Patient (b)(6), female, bilateral knees.

Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

Manufacturer Narrative

The returned instruments were transferred to bioengineering for review, a report was received stating: the complaint of ¿the instrument binded up and would not allow him to match his flexion gap to his extension gap¿ appears to not be justified as the devices were judge to distract appropriately even when the distractor handle and columns were swapped. There was no evidence of galling or thread damage on the parts. This is the first complaint of binding of the balanced sizer received following the implementation of eco425544; these samples give no indication that the eco was not successful in alleviating galling. The failure mode could not be recreated, suggest monitoring for further instances of this complaint with this instrument. The complaint shall be closed with an unjustified conclusion it will be entered into the complaint database and monitored through trend analysis.

• Brand Name: ATTUNE BAL SIZER DISTRACTOR
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4259356
• Report Number: 1818910-2014-31870
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 254400519
• Device Lot Number: ABC30968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• 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 Outcome(s): Required Intervention