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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3TB IN TR/2.5/15MM; KNEE INSTRUMENT : TIBIAL TRIALS
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DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3TB IN TR/2.5/15MM; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 961522
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/29/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 tib tc3 insert size 2.5 15mm was broken.No surgical delay.
 
Additional Manufacturer Narrative
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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Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7615683
Report Number1818910-2018-62611
Device Sequence Number16454496
Product Code LXH
UDI-Device Identifier10603295239352
UDI-Public10603295239352
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 05/29/2018
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 Number961522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Initial Date Received by Manufacturer 05/29/2018
Supplement Date Received by Manufacturer06/20/2018
Initial Report FDA Received Date06/19/2018
Supplement Report FDA Received Date06/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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