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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVE 11/13 +0; ASR HIP SYSTEM : HIP FEMORAL SLEEVE
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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVE 11/13 +0; ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999890340
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Event Date 10/04/2017
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
Asr medical records received.After review of medical records the patient was revised to address osteolysis left tha.Operative notes reported a minimal trunnionosis of the trunnion, some osteolytic fibrinous material was debrided, minor staining were noted at the anterior inferior acetabular margin this was minimal and was debrided, some osteolytic fibrinous material was also debrided.
 
Manufacturer Narrative
(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.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.
 
Event Description
Litigation alleges elevated metal ions, metallosis, adverse reaction to metal debris, and failure of the defective hip device, injury, pain, suffering and emotional distress and presence of fluid.
 
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.Additional narrative: added: description of event or problem and adverse event problem (patient and device).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.H10 additional narrative: added: b5 and h6 (patient code) h6 patient code: no code available (3191) used to capture the device revision or replacement.
 
Event Description
This is to captured the updated harms and codes.
 
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 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.H10 additional narrative: e3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
ADAPTER SLEEVE 11/13 +0
Type of Device
ASR HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key8218183
MDR Text Key132107700
Report Number1818910-2019-79940
Device Sequence Number1
Product Code KWL
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,Followup,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2010
Device Catalogue Number999890340
Device Lot Number2028897
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ASR ACETABULAR CUPS 48; ASR UNI FEMORAL IMPL SIZE 43; S-ROM*SLEEVE PRX ZTT, 18B-SML; SROM*STM ST,30+4L NK,18X13X160
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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