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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG INS TRL CURV12.5MMSZ2.5; KNEE INSTRUMENT : TIBIAL TRIALS
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DEPUY ORTHOPAEDICS INC US PFCSIG INS TRL CURV12.5MMSZ2.5; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 961342
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed breakage and damage.Depuy considers the investigation closed.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 5x10 sigma curved insert trial broke along the bottom lip.
 
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Brand Name
PFCSIG INS TRL CURV12.5MMSZ2.5
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8120118
Report Number1818910-2018-76754
Device Sequence Number13504702
Product Code LXH
UDI-Device Identifier10603295237143
UDI-Public10603295237143
Combination Product (Y/N)N
Initial Reporter StateCA
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) 11/27/2018
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 Number961342
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/27/2018
Initial Report FDA Received Date11/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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