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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TIB TRAY SIZE 4 15MM; KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TIB TRAY SIZE 4 15MM; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 129435415
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 04/08/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).Depuy synthes has been informed that the lot number is not available.
 
Event Description
Patient was revised to address a broken implant.
 
Manufacturer Narrative
The device associated with this report was not returned for evaluation.Photographs of the reported fractured device were provided.Review of the provided photographs confirm the tibial tray stem has broken off the tibial tray.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot code required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause, a need for corrective action is not indicated.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.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
 
Manufacturer Narrative
Additional narrative: examination of the submitted device confirmed the stem fractured due to low stress, high cycle fatigue.There were no inclusions or material defects that could have contributed to crack initiation or propagation.Review of the device history records did not reveal any manufacturing deviations or anomalies.The investigation could not draw any conclusions about the root cause of the verify or identify any product contribution to the low stress, high cycle fatigue with the information provided.No evidence was found indicating product error was a contributing factor the device fracture and the need for corrective action was not indicated.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.
 
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Brand Name
MBT REV TIB TRAY SIZE 4 15MM
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key5607781
MDR Text Key43628283
Report Number1818910-2016-18042
Device Sequence Number1
Product Code NJL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 04/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/04/2017
Device Catalogue Number129435415
Device Lot NumberB5TBM1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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