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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 Problems Difficult to Insert (1316); Off-Label Use (1494)
Patient Problem Not Applicable (3189)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).
 
Event Description
The patient undergo revision surgery due to poly wear that was reported in (b)(4).The liner would not lock into the cup.A second liner was then opened with the same result.The doctor determined that the locking mechanism had been compromised so he elected to cement a liner in place.Doe: (b)(6) 2020, right side.
 
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.
 
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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 Key10130804
MDR Text Key194771401
Report Number1818910-2020-13405
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 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
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 Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACS POLY 20D 28 GR2; ACS POLY 20D 28 GR3; UNKNOWN HIP ACETABULAR CUP
Patient Age61 YR
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