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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 50OD; HIP CERAMIC ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 50OD; HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121882750
Device Problem Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)
Event Date 02/14/2024
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Hip revision due to unknown pain.The ceramic insert and the ceramic has been changed due to strange ceramic bearing.The head has a black mark on the side.The soft tissue seems to have some kind of metallosis.Doi: (b)(6) 2015 doe: (b)(6) 2024 reason for revision surgery.--> problem with the ceramic bearing, pain.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
DELTA CER INSERT 32ID X 50OD
Type of Device
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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18763711
MDR Text Key336053364
Report Number1818910-2024-04090
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number121882750
Device Lot Number7954943
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/26/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PINN SECTOR W/GRIPTION 50MM.
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
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