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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 47MM OD HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

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DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 47MM OD HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI Back to Search Results
Model Number 1363-47-000
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
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
During opening, the material sticker was already on the implant - the customer did not want do implant that. A new implant was opened.
 
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Brand NameMODULAR CATHCART BALL 47MM OD
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12025496
MDR Text Key261964980
Report Number1818910-2021-12995
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K903084
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 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1363-47-000
Device Catalogue Number136347000
Device Lot NumberD20102089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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