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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK TIBIAL TRIAL
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DEPUY ORTHOPAEDICS INC US UNK TIBIAL TRIAL Back to Search Results
Catalog Number UNK TIBIAL TRIAL
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 08/20/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).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 when the insert trial was removed, it was noticed that one of the posts/springs that locks into the trial shim was missing from the articulating surface.X-ray was called to confirm the spring was not missing in the patient.At the time of x-ray we were made aware that a 14x30 stem trial was still in the patient.Stem trial was then retrieved from patient.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK TIBIAL TRIAL
Type of Device
TIBIAL TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12460365
MDR Text Key271044139
Report Number1818910-2021-19936
Device Sequence Number1
Product Code NJL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK TIBIAL TRIAL
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN KNEE TIBIAL STEM; UNKNOWN KNEE TIBIAL STEM
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