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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 TB TRAY TRL W/STEM SZ 2.5; KNEE INSTRUMENT : TIBIAL STEM TRIALS
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DEPUY ORTHOPAEDICS INC US SP*2 TB TRAY TRL W/STEM SZ 2.5; KNEE INSTRUMENT : TIBIAL STEM TRIALS Back to Search Results
Catalog Number 966402
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event or Problem Description
It was reported the instruments were bent at bottom.No surgical delay.
 
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Common Device Name
KNEE INSTRUMENT : TIBIAL STEM TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7761535
Report Number1818910-2018-66021
Device Sequence Number1258685
Product Code LXH
UDI-Device Identifier10603295248347
UDI-Public10603295248347
Combination Product (Y/N)N
Initial Reporter StateMA
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) 07/13/2018
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 Number966402
Device Lot NumberH1196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/13/2018
Initial Report FDA Received Date08/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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