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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US VMP + DEPUY CMW 3G 50G; BONE CEMENT : BONE CEMENT
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DEPUY ORTHOPAEDICS INC US VMP + DEPUY CMW 3G 50G; BONE CEMENT : BONE CEMENT Back to Search Results
Catalog Number 3005050
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
Bone cement was damaged and physician couldn`t use them at all.No consequences for the patient reported.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this complaint was received at blackpoll.The investigation confirmed the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2022-11536 is being retracted since it was found to be a duplicate of mrf# 1818910-2021-15390.Mfr# 1818910-2021-15390 will be kept for investigation purposes.
 
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Brand Name
VMP + DEPUY CMW 3G 50G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK   FY4 4QQ
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14786641
MDR Text Key302183501
Report Number1818910-2022-11536
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodePL
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
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3005050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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