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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 56OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 56OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1245-80-051
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 06/16/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised due to hip pain.Doi: (b)(6) 2002, dor: (b)(6) 2020, affected site: unknown.
 
Additional 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
DURALOC SECTOR SERIES 56OD
Common Device Name
DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10201079
Report Number1818910-2020-14537
Device Sequence Number1073422
Product Code LPH
UDI-Device Identifier10603295019602
UDI-Public10603295019602
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K961186
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number1245-80-051
Device Catalogue Number124580051
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/16/2020
Supplement Date Received by Manufacturer08/11/2020
Initial Report FDA Received Date06/26/2020
Supplement Report FDA Received Date08/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; ENDURON NEUT 56 OR 68ODX32ID; TOTAL HIP BALL 32 MM +5; APEX HOLE ELIM POSITIVE STOP; DUR DYNAMIC LOCK RING 56 OR 68; ENDURON NEUT 56 OR 68ODX32ID; TOTAL HIP BALL 32 MM +5
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
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