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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 Problem Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 04/23/2020
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 on (b)(6) 2008 via tha.It was reported that the patient broke her knee 2 weeks ago.1 week ago, the patient underwent surgery for the knee fracture.It was confirmed that the patient¿s left hip joint¿s dislocation occurred by x-ray after the surgery for the fracture.The dislocation was seemed to occur when the surgeon tugged in the surgery.On (b)(6) 2020, the revision surgery was performed for the dislocation by replacing the liner and the head.The revision surgery was completed, and it was unknown whether there was any surgical delay.The patient is in rehabilitation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Additional information indicated that the affected side was the left hip.
 
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =examination of the returned device finds nothing outward to suggest product error.Through examination of provided x-ray images it is possible to confirm the reported allegation of disassociation but not the dislocation event.Information provided has stated the event occurred during a surgery for another reason.No product error is suspected.The information received will be retained for potential series investigations if triggered by trend analysis 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 = the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).The lot code required also remains unknown.
 
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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 Key10014371
MDR Text Key189718221
Report Number1818910-2020-11552
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 company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number962711000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PINNACLE MTL INS NEUT36IDX58OD; PINNACLE MTL INS NEUT36IDX58OD; PINNACLE MTL INS NEUT36IDX58OD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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