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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ACETABULAR TRIAL
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DEPUY ORTHOPAEDICS INC US UNK ACETABULAR TRIAL Back to Search Results
Catalog Number UNK ACETABULAR TRIAL
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 01/10/2020
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 during the removal of the liner trial the ring and screw attachment portion of the liner trial came disengaged.The liner trial was damaged and a new one needs to be sent to memorial regional.Surgical delay: 5 min.
 
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.Patient code: removed not applicable code and replaced with no code available (3191) to capture prolonged surgery and insufficient information.
 
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Brand Name
UNK ACETABULAR TRIAL
Type of Device
UNK ACETABULAR TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10311389
MDR Text Key200985087
Report Number1818910-2020-16623
Device Sequence Number1
Product Code KWA
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 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK ACETABULAR TRIAL
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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