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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON NEUT 56 OR 68ODX32ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US ENDURON NEUT 56 OR 68ODX32ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 124216025
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 06/16/2020
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
The patient was revised due to hip pain.Doi: (b)(6) 2002, dor: (b)(6) 2020, affected site: unknown.
 
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, post market surveillance, 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.H10 additional narrative: corrected: h5.
 
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Brand Name
ENDURON NEUT 56 OR 68ODX32ID
Type of Device
DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10201035
MDR Text Key196602915
Report Number1818910-2020-14541
Device Sequence Number1
Product Code HRY
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number124216025
Device Lot NumberV1WHV1005
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; DURALOC SECTOR SERIES 56OD; TOTAL HIP BALL 32 MM +5; APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; DURALOC SECTOR SERIES 56OD; TOTAL HIP BALL 32 MM +5
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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