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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121725500
Device Problem Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 12/01/2014
Event Type  Injury  
Event Description
Patient was revised to address a vertical cup and pain.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
 
Manufacturer Narrative
This report is still considered closed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy still considers this investigation closed at this time.
 
Event Description
Update 8/21/15-pfs and medical records received.After review of the medical records for mdr reportability, the medical records indicate increased metal ions (no labs).No revision operative note was provided.The stem is being added to the complaint.The complaint was updated on:9/17/2015.
 
Manufacturer Narrative
Correction: manufacturing facility: (b)(4).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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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.
 
Manufacturer Narrative
Product complaint #(b)(4).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.   h10 additional narrative: added: b5 and h6 (patient code).
 
Event Description
Ppf alleges metal wear.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX25MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key4357542
MDR Text Key5203226
Report Number1818910-2014-35063
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 Health Professional,Distributor,consumer,distributor,he
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/12/2010
Device Catalogue Number121725500
Device Lot NumberZ4XA54000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/27/2015
Initial Date FDA Received12/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
08/14/2019
11/11/2019
Supplement Dates FDA Received03/09/2015
04/29/2015
12/02/2015
08/16/2019
11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient Weight101
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