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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 962711000
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
Event Date 01/01/2020
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, (b)(6) 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.
 
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.Device history lot : 2583596.Device history review : no anomalies found.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).No code available (3191) used to capture no information available.Added: d11 and h6 device code corrected: h6 (patient code: joint dislocation is being retracted as there is no reported dislocation in the event).
 
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.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.Device history lot: 2583596.Device history review: no anomalies found.
 
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Brand Name
9/10 ULTAMET 36MM HEADS +0
Type of Device
SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key9978559
MDR Text Key188263315
Report Number1818910-2020-10993
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 foreign,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number962711000
Device Lot Number2583596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
C-STEM SZ4 HIGH OFFSET; C-STEM SZ4 HIGH OFFSET; 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; C-STEM SZ4 HIGH OFFSET; PINNACLE MTL INS NEUT36IDX58OD; S-ROM SCREW,6.5MM DIA,25MM LG; S-ROM SCREW,6.5MM DIA,35MM LG
Patient Outcome(s) Required Intervention;
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