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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR 10D 580DX36ID; HIP INSTRUMENTS : ACETABULAR TRIALS
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DEPUY ORTHOPAEDICS INC US PIN TRL LNR 10D 580DX36ID; HIP INSTRUMENTS : ACETABULAR TRIALS Back to Search Results
Catalog Number 221836158
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.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 liner trial damaged taking out.No surgical delay.
 
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Brand Name
PIN TRL LNR 10D 580DX36ID
Common Device Name
HIP INSTRUMENTS : ACETABULAR TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8174839
Report Number1818910-2018-78533
Device Sequence Number1987054
Product Code LXH
UDI-Device Identifier10603295101291
UDI-Public10603295101291
Combination Product (Y/N)N
Initial Reporter StateNE
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) 11/21/2018
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 Number221836158
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/21/2018
Initial Report FDA Received Date12/18/2018
Patient Sequence Number1
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