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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254400519
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 10/21/2014
Event Type  malfunction  
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.
 
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.
 
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Brand NameATTUNE BAL SIZER DISTRACTOR
Type of DeviceKNEE 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 Key4259356
MDR Text Key12561200
Report Number1818910-2014-31870
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number254400519
Device Lot NumberABC30968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2015
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 Treatment Data
Date Received: 11/18/2014 Patient Sequence Number: 1
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