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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +5; ASR HIP SYSTEM : HIP FEMORAL SLEEVE
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DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +5; ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800315
Device Problems Corroded (1131); Biocompatibility (2886)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Event Date 02/15/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: lawyer.
 
Event Description
Update ad 05 apr 2019.Asr litigation records received alleging elevated blood heavy metal ion levels, injury, pain and suffering.Update ad 10 apr 2019.Medical records received.After review of medical records, the patient was revised to address a failed left total hip replacement secondary to metal-on-metal wear.Operative findings include a large pseudotumor, corrosion on the trunnion, abundant amounts of fluid with whitish debris and scar tissue.
 
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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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.
 
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Brand Name
ADAPTER SLEEVES 12/14 +5
Type of Device
ASR HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key8551947
MDR Text Key143121707
Report Number1818910-2019-91668
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2011
Device Catalogue Number999800315
Device Lot Number2274906
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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