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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN DEPUY POLY LINER; HIP ACETABULAR INSERT/LINER
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DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN DEPUY POLY LINER; HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number UNK-HIP
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Pain (1994); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 12/15/2008
Event Type  Injury  
Event Description
Legal claim received.Update rec'd 7/30/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, discomfort, symptoms of loose implant.Doi year was provided.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update rec'd 7/31/2014- pfs and medical records received.After review of the medical records a correct doi and dor were provided.This complaint originally came in under an asr legal claim, but the medical records show the patient had an odyssey hip symptom implanted on (b)(6) 1994.He was then revised on (b)(6) 2008 to a pinnacle system.The original odyssey stem was retained.He was revised for acetabular erosion and osteolysis.An unknown cup and stem are being added to the complaint as they cannot be excluded as the cause of pain which was alleged by litigation.There is no new additional information that would affect the existing mdr decision.
 
Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN DEPUY POLY LINER
Type of Device
HIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw 46582
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743714918
MDR Report Key3987069
MDR Text Key4885432
Report Number1818910-2014-25223
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Reporter Occupation Attorney
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK-HIP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight118
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