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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP MBT TRAY TRIAL SIZE 4; KNEE INSTRUMENT : TIBIAL BASE PLATES
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DEPUY ORTHOPAEDICS INC US HP MBT TRAY TRIAL SIZE 4; KNEE INSTRUMENT : TIBIAL BASE PLATES Back to Search Results
Catalog Number 950502006
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/19/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the hp 4-7 punch has broken small spine.Mbt tray size 4, the hole where the pin goes will not go through.Attune femoral sizer, paint is coming off.
 
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Brand Name
HP MBT TRAY TRIAL SIZE 4
Common Device Name
KNEE INSTRUMENT : TIBIAL BASE PLATES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7681986
Report Number1818910-2018-64294
Device Sequence Number1554297
Product Code LXH
UDI-Device Identifier10603295227267
UDI-Public10603295227267
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2018
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
Operator of Device Health Professional
Device Catalogue Number950502006
Device Lot NumberJ0309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/19/2018
Initial Report FDA Received Date07/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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