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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ4 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM
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DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ4 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 9611-72-000
Device Problems Degraded (1153); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
Event Date 04/11/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The primary surgery was performed about 10 years ago (the date was unknown) via tha with the head (p/n: 962711000), the stem (p/n: 961172000), the liner (p/n: 121887358) and the cup (p/n: 121780058, kyocera's product).It was reported that on an unknown date, the dislocation of the head was occurred.The revision surgery was scheduled on (b)(6) 2020.The reason of the dislocation was unknown.No further information is available.The revision surgery was performed on (b)(6) 2020 by replacing the stem, the liner and the head (the head was dislocated in the body).The surgeon commented that the trunnion of the stem was seemed black corrosion in a wide sphere, and the corrosion might caused the dislocation of the head.It was confirmed that the screws and cup (kyocera's product) were not returned.They were remained in the body.
 
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
Product complaint # (b)(4).Investigation summary : the devices were returned for investigation.No product defects were noted.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the devices were returned for investigation.No product defects were noted.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Addendum added 16-september-2020.Following receipt of additional photographs, the investigation was re-opened and the photographs transferred to depuy bioengineering for review, with notification received that: ¿these images do not alter the findings of the previous bioengineering report.¿ no changes were required to the previous investigation conclusions.
 
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Brand Name
C-STEM SZ4 HIGH OFFSET
Type of Device
C-STEM HIP IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10002475
MDR Text Key190539147
Report Number1818910-2020-11393
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295235279
UDI-Public10603295235279
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 04/06/2020
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? Yes
Device Operator Health Professional
Device Model Number9611-72-000
Device Catalogue Number961172000
Device Lot Number2246566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Initial Date Manufacturer Received 04/06/2020
Initial Date FDA Received04/27/2020
Supplement Dates Manufacturer Received04/17/2020
06/22/2020
09/28/2020
Supplement Dates FDA Received05/05/2020
06/23/2020
09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
9/10 ULTAMET 36MM HEADS +0; 9/10 ULTAMET 36MM HEADS +0; COMPETITOR ACETABULAR CUP; PINNACLE MTL INS NEUT36IDX58OD; PINNACLE MTL INS NEUT36IDX58OD; S-ROM*SCREW,6.5MM DIA,25MM LG; S-ROM*SCREW,6.5MM DIA,25MM LG; S-ROM*SCREW,6.5MM DIA,35MM LG; S-ROM*SCREW,6.5MM DIA,35MM LG
Patient Outcome(s) Required Intervention;
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