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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FEMORAL IMPACTOR; KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FEMORAL IMPACTOR; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254401006
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2016
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
A piece broke off of the attune femoral impactor.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
Additional narrative: conclusion and justification status for mdr: the complaint states a piece broke off of the attune femoral impactor.Per der, no delay & no pieces left in patient.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune femoral impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.The annealed product was released on 30-jul-2014.This device is from an un-annealed batch.A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
 
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Brand Name
ATTUNE FEMORAL IMPACTOR
Type of Device
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key5575037
MDR Text Key42608235
Report Number1818910-2016-17324
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 distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/11/2016
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
Device Catalogue Number254401006
Device Lot NumberAU3654033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2016
Initial Date FDA Received04/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/20/2016
05/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age62 YR
Patient Weight66
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