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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX40MM; HIP OTHER IMPLANT- SCREW
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX40MM; HIP OTHER IMPLANT- SCREW Back to Search Results
Catalog Number 121740500
Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)
Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Inadequate Osseointegration (2646)
Event Date 11/30/2012
Event Type  Injury  
Event Description
Litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update rec'd 1/8/2014- pfs and medical records received.Part/lot was provided.Revision operative notes indicate a loose cup.The cup and screw have now been reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 1/30/2014.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The investigation is ongoing.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
No device associated with this report was received for examination.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
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ppf alleges loosening of cup and stem, and metal wear/ metallosis.It was previously indicated in the medical records that the stem was not revised.
 
Manufacturer Narrative
(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX40MM
Type of Device
HIP OTHER IMPLANT- SCREW
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key3600674
MDR Text Key19974183
Report Number1818910-2014-11868
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,consumer,other
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number121740500
Device Lot Number588321
Was Device Available for Evaluation? No
Date Manufacturer Received10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight62
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