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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C & MOD CATH TRL 52/28; HIP INSTRUMENTS : ACETABULAR TRIALS
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DEPUY ORTHOPAEDICS INC US S/C & MOD CATH TRL 52/28; HIP INSTRUMENTS : ACETABULAR TRIALS Back to Search Results
Catalog Number 205552000
Medical Device Problem Code Illegible Information (4050)
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: examination of the returned instrument confirmed the reported observation.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 bi polar trials not functioning properly and/or hard to read.No surgical delay.
 
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Brand Name
S/C & MOD CATH TRL 52/28
Common Device Name
HIP INSTRUMENTS : ACETABULAR TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8232695
Report Number1818910-2019-80377
Device Sequence Number1621251
Product Code LXH
UDI-Device Identifier10603295084693
UDI-Public10603295084693
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) 01/03/2019
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 Number205552000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/03/2019
Initial Report FDA Received Date01/09/2019
Patient Sequence Number1
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