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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR +4 NEUT LNR 36X60; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US DUR MAR +4 NEUT LNR 36X60; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1220-36-460
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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 to address instability.Doi: (b)(6) 2017, dor: (b)(6) 2020, right side.
 
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
DUR MAR +4 NEUT LNR 36X60
Common Device Name
DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10191444
Report Number1818910-2020-14383
Device Sequence Number3017398
Product Code LPH
UDI-Device Identifier10603295015727
UDI-Public10603295015727
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K010171
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 06/12/2020
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 Number1220-36-460
Device Catalogue Number122036460
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/12/2020
Supplement Date Received by Manufacturer08/05/2020
Initial Report FDA Received Date06/24/2020
Supplement Report FDA Received Date08/05/2020
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
DLT TS CER HD 12/14 36MM +1.5; DUR DYNAMIC LOCK RING 60 OR 72; DLT TS CER HD 12/14 36MM +1.5; DUR DYNAMIC LOCK RING 60 OR 72
Outcome Attributed to Adverse Event Required Intervention;
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