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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881756
Device Problems Fracture (1260); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 02/17/2021
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 ceramic insert broke. Patient report hearing noises in hip. Revision of moving parts, date 1st surgical procedure (b)(6) 2020.

 
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Brand NameDELTA CER INSERT 36ID X 56OD
Type of DevicePINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11400085
MDR Text Key234293895
Report Number1818910-2021-04184
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeSZ
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
Report Date 02/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121881756
Device LOT Number9386695
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2020
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: 03/02/2021 Patient Sequence Number: 1
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