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 US SUMMIT POR TAPER SZ7 STD OFF; 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 US SUMMIT POR TAPER SZ7 STD OFF; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 157001135
Device Problems Corroded (1131); Degraded (1153); Loss of Osseointegration (2408); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Hypoesthesia (2352); Osteolysis (2377); Sweating (2444); Inadequate Osseointegration (2646); Test Result (2695); No Information (3190); No Code Available (3191)
Event Date 02/24/2015
Event Type  Injury  
Event Description
Patient was revised to address stem loosening.
 
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.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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 complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
 
Event Description
Update 2/8/16-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, alval, osteolysis, and corrosion.The alval reaction was reported to have "eaten" away 1/2 of the femur exposing the stem.The stem was revised and while removed the stem, a crack occured.The stem was noted to be ingrown, no loosening was noted.Part/lot is being updated.The complaint was updated on: 2/29/2016.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or insert.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combination.The investigation can draw no conclusions with the information provided.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 this investigation closed at this time.
 
Event Description
Update 4/28/16-pfs and medical records received.Pfs reported patient felt looseness, developed a-fib, swelling, numbness, shortness of breath, sweating and pain.Medical records reported alval lesion, dramatic amounts of osteolysis with femur and acetabulum, corrosion on the taper, femoral head, liner and cup, the femur was reported to have a crack after use of osteotomes to remove femoral stem and estimated blood loss of 950ml during procedure.The complaint was updated on: may 20, 2016.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or insert.Per procedure, these devices are exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations for the stem or acetabular cup.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.  udi: (b)(4).
 
Event Description
Ppf alleges pseudotumor, metal wear, metallosis, and elevated metal ions.
 
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.Additional narrative: no code available is to capture surgical intervention.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
SUMMIT POR TAPER SZ7 STD OFF
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key4573310
MDR Text Key5545884
Report Number1818910-2015-15416
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
PK001991
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 02/24/2015
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 Catalogue Number157001135
Device Lot NumberY5RGK1000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/12/2015
Initial Date FDA Received03/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
03/18/2019
01/03/2020
Supplement Dates FDA Received03/18/2015
11/19/2015
12/07/2015
03/09/2016
03/31/2016
05/20/2016
06/27/2016
04/01/2019
01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight112
-
-