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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP; ACETABULAR TRIAL
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP; ACETABULAR TRIAL Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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
Trial dual mobility liner size 56/49 got stuck in shell cross threaded.Was unable to remove.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.  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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN HIP ACETABULAR CUP
Type of Device
ACETABULAR TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11862647
MDR Text Key251933239
Report Number1818910-2021-10894
Device Sequence Number1
Product Code HWT
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 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
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 Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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