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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 28ID X 58OD HIP IMPLANT CERAMIC ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 28ID X 58OD HIP IMPLANT CERAMIC ACETABULAR LINER Back to Search Results
Catalog Number 121883758
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/02/2021
Event Type  Injury  
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 Description

Due to the appearance of luxation and squeaking, the patient goes for a revision, when surgeon opening the patient, the appearance of metallosis is seen due to which they had to remove the cup the new revision date was (b)(6) 2021 where all these components have been removed and new ones installed. Date of initial surgery(b)(6) 2006. Affected side-left.

 
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Brand NameDELTA CER INSERT 28ID X 58OD
Type of DeviceHIP IMPLANT CERAMIC ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11697484
MDR Text Key246446901
Report Number1818910-2021-08330
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeHR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 03/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2015
Device Catalogue Number121883758
Device LOT Number3217401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/18/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/20/2021 Patient Sequence Number: 1
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