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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVE 11/13 +3 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVE 11/13 +3 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999890343
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Edema (1820); Fever (1858); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Tissue Damage (2104); Discomfort (2330); Hypoesthesia (2352); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Event Date 06/03/2011
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.
 
Event Description
New ecm record created in order to update legacy complaint (b)(4). New etq record created in order to update etq (legacy system) complaint number (b)(4). Reason for original complaint. Litigation papers allege: patient was implanted with a depuy asr hip on (b)(6) 2009. Patient experienced pain, inhibition of the ability to walk, unnecessary and additional surgery, and other injuries presently undiagnosed. Patient has been and/or will be forced to undergo a revision surgery. Doi: (b)(6) 2009 - dor: n/i. Patient is a resident of (b)(6). Update 8/8/12 - plaintiff¿s preliminary disclosure form was received, which identified (part/lot) information. The complaint and associated mdrs were updated. There was no new information that would change the outcome of the investigation. Update 09/23/13 - plaintiff¿s preliminary disclosure form was received with medical documents, which identified dob, doi, dor, side information. The complaint and associated mdrs were updated. There was no new information that would change the outcome of the investigation. Doi: (b)(6) 2009 - dor: (b)(6) 2012 (left hip). Update ad 20 dec 2019. (b)(4) has been reopened under (b)(4) due to receipt of pfs and medical records. Pfs alleges pain while walking and bending over, inability to do day to day activities, pseudotumors, fluid in the joint, metallosis and necrosis. Medical records report pain, bleeding from the operative side, seroma, sanguineous drainage, fall, stiffness, osteolysis, swelling, soreness, numbness, fever, inability to walk or sit, mild tenderness to palpation of the hip, loosening of the acetabular component, wound dehiscence, poor wound healing, implant noise, seroma and avulsion of the abductor medius. Patient had multiple complications leading to multiple surgical interventions: debridement of wound and placement of rectus femoris muscle flap (b)(6) 2010, incision and drainage on (b)(6) 2009, irrigation and debridement with application of wound vac on (b)(6) 2009, debridement on (b)(6) 2009. Surgical pathology reports significant acute inflammation. Left hip aspiration on (b)(6) 2012 indicates approximately 6 cc of brown, purulent fluid. The patient was then revised to address an infected left hip on (b)(6) 2012. The hip was described as having gross purulence, a large amount of synovitic response and a very thickened pseudo capsule. The asr cup was noted to have 0% bony ingrowth. Doi: (b)(6) 2009 - dor: (b)(6) 2012 (left hip).
 
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Brand NameADAPTER SLEEVE 11/13 +3
Type of DeviceASR HIP SYSTEM : HIP FEMORAL SLEEVE
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 Key9924279
MDR Text Key189894920
Report Number1818910-2020-10022
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 06/03/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999890343
Device Lot Number2129463
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2006
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: 04/03/2020 Patient Sequence Number: 1
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