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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2006
Event Type  Injury  
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
Cup revision due to wear.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
UNKNOWN HIP ACETABULAR CUP
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10976850
MDR Text Key220472268
Report Number1818910-2020-26594
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,foreig
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
J-LOC 46MM X 28MM ID 10 DEGREE; J-LOC 46MM X 28MM ID 10 DEGREE
Patient Outcome(s) Required Intervention;
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