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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV CEM STEM REAMER 13MM; KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV CEM STEM REAMER 13MM; KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863185
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the revision chuck would not attach properly to the reamer.It would not seat down correctly and was not able to be used.It did not delay our surgery since we had another reamer that we could use in its place.It was just one piece so it will be returned.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported damage.Depuy considers the investigation closed.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.
 
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Brand Name
MBT REV CEM STEM REAMER 13MM
Type of Device
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7464702
MDR Text Key106631358
Report Number1818910-2018-58325
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295096429
UDI-Public10603295096429
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/02/2018
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
Device Operator Health Professional
Device Catalogue Number217863185
Device Lot NumberA0810
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2018
Initial Date FDA Received04/26/2018
Supplement Dates Manufacturer Received06/26/2018
Supplement Dates FDA Received07/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age67 YR
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