Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Synovitis (2094); Tissue Damage (2104); Weakness (2145); Ambulation Difficulties (2544)
Event Date 06/07/2016
Event Type  Injury  
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.Depuy synthes has been informed that the catalog number and lot number is not available.
 
Event Description
Patient was revised to address elevated ions and pain.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been 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
Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Update rec¿d 03/20/2017 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from metallosis.
 
Event Description
Update 14 jul 2017: medical records received.In addition to what was previously alleged, pfs also alleges limping and weakness.After review of medical records for mdr reportability it was reported that the patient was revised to address pain and synovitis.Revision notes reported component wear, instability, and capsular laxity.The cup was well fixed and in good position without any significant osteolysis.Laboratory result for cobalt is above 7ppb.This complaint was updated on: 04 aug 2017.
 
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. .
 
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).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.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 will be filed as appropriate.
 
Event Description
Complaint description: patient was revised to address elevated ions and pain.Update rec¿d 03/20/2017 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from metallosis.There is no new information that would change the existing mdr decision.Complaint was updated 03/28/2017 update 14 jul 2017: medical records received.In addition to what was previously alleged, pfs also alleges limping and weakness.After review of medical records for mdr reportability it was reported that the patient was revised to address pain and synovitis.Revision notes reported component wear, instability, and capsular laxity.The cup was well fixed and in good position without any significant osteolysis.Laboratory result for cobalt is above 7ppb.This complaint was updated on: 04 aug 2017./ | investigation method: the patient is considered obese.It is stated in the warnings and precautions that excessive patient weight tends to adversely affect hip replacement implants.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.No additional event information or investigational inputs were provided to customer quality.The investigation can draw no conclusion regarding the reported event with the information available.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event./ | investigation summary: patient was revised to address elevated ions and pain.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.
 
Event Description
Updated code for metallosis.
 
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
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key5736985
MDR Text Key47790470
Report Number1818910-2016-21777
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 distributor,health profession
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight92
-
-