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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNKNOWN SROM FEMORAL SLEEVE; HIP FEMORAL STEM/SLEEVE
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DEPUY IRELAND - 9616671 UNKNOWN SROM FEMORAL SLEEVE; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK-HIP
Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)
Patient Problems Pain (1994); Swelling (2091)
Event Date 11/27/2013
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.Depuy synthes has been informed that the catalog number and lot number is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation alleges that the patient suffers from pain, swelling, clicking/popping and grinding.Update 01/04/2017 sales rep has reported a revision due to broken femoral stem and loosening.
 
Manufacturer Narrative
No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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, a follow-up medwatch will be filed as appropriate.
 
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).
 
Event Description
Ppf alleges dislocation and elevated metal ions after the first revision.Added revision hospital, law firm, new lawyer, patient middle initial and updated product details.
 
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Brand Name
UNKNOWN SROM FEMORAL SLEEVE
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key6253030
MDR Text Key64917772
Report Number1818910-2017-10906
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
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK-HIP
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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