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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 56 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 56 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999830756
Device Problem Noise, Audible (3273)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 11/04/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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. Addendum added (b)(6) 2020. Following further review, it was identified that this was an asr product. The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. Ref. (b)(4) superseded by (b)(4).
 
Event Description
 patient had s depuy asr total acetabular implant. The letter alleges pain, functional limitations, rise in chromium and cobalt ions in blood and urine, articular crepitation and distress. The patient then underwent right hip revision surgery and it was observed that there was rough ossification departing from the femoral neck up to the acetabulum, brownish fluid and metallosis. Histological examination indicates chronic non-specific synovitis with an area of sclerosis and meta-hemorrhage foci. Added lawyer, patient date of birth, patient sex, date of implant, operative hip, patient harms, date of explant/event date, implant duration, patient and pe codes, revising surgeon and surgeon. Doi: (b)(6) 2007 - dor: (b)(6) 2015 (right hip).
 
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Brand NameASR 300 SPIKED CUP SIZE 56
Type of DeviceASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9935550
MDR Text Key189705367
Report Number1818910-2020-10404
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Remedial Action Recall
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number999830756
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 04/08/2020 Patient Sequence Number: 1
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