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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800312
Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/31/2018
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. Concomitant med products: asr uni femoral impl size 55; adapter sleeves 12/14 +2; asr acetabular cups 62; summit duofix tap sz7 std off. No pma/510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically.
 
Event Description
Patient was revised to address suspected high metal ion levels, metallosis, and pseudotumor, also trunionosis documented. Surgeon removed depuy asr metal on metal hip and replaced it with modular pinnacle cup with ceramic on poly articulation. Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip,.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr ligation received. In addition to what was previously alleged, litigation alleges injury, pain, disfigurement, and emotional distress.
 
Manufacturer Narrative
Pc(b)(4). 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. 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 NameADAPTER SLEEVES 12/14 +2
Type of DeviceASR HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key7819123
MDR Text Key118313924
Report Number1818910-2018-67775
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 Other,Consumer,Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/31/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2012
Device Catalogue Number999800312
Device Lot Number2317241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2007
Is the Device Single Use? Yes
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: 08/27/2018 Patient Sequence Number: 1
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