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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA C/R FEM LFT SZ2.5TRL; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US PFC SIGMA C/R FEM LFT SZ2.5TRL; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Catalog Number 961008
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device found the device could not be disassembled from the mating instrument.Depuy synthes 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.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
Device could not be disassembled from the the mating instrument.
 
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Brand Name
PFC SIGMA C/R FEM LFT SZ2.5TRL
Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8248280
Report Number1818910-2019-80964
Device Sequence Number1582775
Product Code LXH
UDI-Device Identifier10603295234623
UDI-Public10603295234623
Combination Product (Y/N)N
Initial Reporter StateNC
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) 12/20/2018
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 Number961008
Device Lot NumberJ0200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/20/2018
Initial Report FDA Received Date01/15/2019
Patient Sequence Number1
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