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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* FLUT TIB ROD TRL 75 X 12; KNEE INSTRUMENT : TIBIAL STEM TRIALS
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DEPUY ORTHOPAEDICS INC US PFC* FLUT TIB ROD TRL 75 X 12; KNEE INSTRUMENT : TIBIAL STEM TRIALS Back to Search Results
Catalog Number 866875
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 12/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device and radiograph confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
Tibial trial broke during surgery, the tip of the trial stem was fixed in the tibial canal, and broke when extracted.They tried to extract the tip without any luck.
 
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Common Device Name
KNEE INSTRUMENT : TIBIAL STEM TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8235838
Report Number1818910-2019-80483
Device Sequence Number16196973
Product Code LXH
UDI-Device Identifier10603295217572
UDI-Public10603295217572
Combination Product (Y/N)N
Initial Reporter CountryDA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/13/2018
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 Number866875
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/13/2018
Initial Report FDA Received Date01/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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