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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP PST AUG TRL 10MM STD; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US LCS COMP PST AUG TRL 10MM STD; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Catalog Number 229427041
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device confirmed the reported breakage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 pegs broke off.
 
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Brand Name
LCS COMP PST AUG TRL 10MM STD
Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8264325
Report Number1818910-2019-81585
Device Sequence Number11138217
Product Code LXH
UDI-Device Identifier10603295112969
UDI-Public10603295112969
Combination Product (Y/N)N
Initial Reporter StatePA
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) 12/31/2018
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 Number229427041
Device Lot NumberH0904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/31/2018
Initial Report FDA Received Date01/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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