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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV PRIMARY CONICAL REAMER; KNEE INSTRUMENT : REAMERS
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DEPUY ORTHOPAEDICS INC US MBT REV PRIMARY CONICAL REAMER; KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863199
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination and functional testing of the returned device confirmed the reported event.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 reamer and the reamer adapter connections are worn and need to be replaced.No surgical delay.
 
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Brand Name
MBT REV PRIMARY CONICAL REAMER
Common Device Name
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8200306
Report Number1818910-2018-79252
Device Sequence Number1929108
Product Code HTO
UDI-Device Identifier10603295096535
UDI-Public10603295096535
Combination Product (Y/N)N
Initial Reporter StateSC
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) 11/30/2018
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 Number217863199
Device Lot NumberPG0608
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 11/30/2018
Initial Report FDA Received Date12/27/2018
Patient Sequence Number1
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