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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121730500
Device Problem Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Pain (1994)
Event Date 08/08/2012
Event Type  Injury  
Event Description
Update rec'd (b)(6) 2014 - sales rep reported revision surgery for the right hip.Patient was revised to address pain.The femoral stem, acetabular cup, and screw are now being added to the complaint.The complaint was updated on: (b)(6) 2014.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: (b)(4).
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Ppf alleges metal wear, metallosis and elevated metal ions, however metal wear and elevated metal ions were already reported.After review of medical records, patient was revised to address failed right metal on metal hip replacement, he has failed due to pain.Revision notes stated that the patient had corrosion between the metal liner and metal shell.He also had metallosis of the synovium which was mild.It was grey to light black- tinged synovium.
 
Manufacturer Narrative
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. udi: (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX30MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key4273870
MDR Text Key5003629
Report Number1818910-2014-32410
Device Sequence Number1
Product Code NDJ
Combination Product (y/n)N
PMA/PMN Number
PK983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Type of Report Initial,Followup,Followup,Followup
Report Date 10/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/18/2020
Device Catalogue Number121730500
Device Lot Number419146
Was Device Available for Evaluation? No
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient Weight75
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