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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ8 HI OFF; HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ8 HI OFF; HIP FEMORAL STEM Back to Search Results
Catalog Number 157011150
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 08/08/2012
Event Type  Injury  
Event Description
New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint.- patient was revised to address hip swelling and pain upon activity.Update: 9/24/13 - litigation papers received.Litigation alleges that the patient suffers from discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.There is no additional information that would affect the outcome of this investigation.Update has been electronically attached to the complaint document.Update 11/20/2014- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated metallosis.The stem is being added for the alleged high metal ions (no lab results provided).There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 12/16/2014.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: unavailable see section d for any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
 
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 a.
 
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.Product complaint # (b)(4).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.Device history lot = null.Device history batch = null.Device history review = null.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
SUMMIT POR TAPER SZ8 HI OFF
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key4335205
MDR Text Key5216717
Report Number1818910-2014-34435
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,company representative,oth
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/20/2014
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 Physician
Device Catalogue Number157011150
Device Lot NumberEL7CF1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2015
Initial Date FDA Received12/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
01/01/2019
Supplement Dates FDA Received02/26/2015
03/30/2015
01/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight90
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