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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE SHIM SZ7 6MM; KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. ATTUNE SHIM SZ7 6MM; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254500672
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 08/24/2015
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned device confirms the reported event of trial breakage.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following 25,000 and 50,000 surgeries, inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted (b)(4) updates where applicable.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.Based on the root cause of suspected misuse, corrective action is not needed.Monitor subsequent reports via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).
 
Event Description
When getting the shim and articulating surface out after trialing, the shim broke in the middle.
 
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Brand Name
ATTUNE SHIM SZ7 6MM
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 Key5049369
MDR Text Key24896511
Report Number1818910-2015-29559
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
Report Date 08/24/2015
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 Number254500672
Device Lot NumberMVMBCK590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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