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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 TAPER SLEEVE ADAPTER 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Injury (2348); No Code Available (3191)
Event Date 05/28/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). No 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Please find attached details w. R. T asr hip implant first left leg total hip replacement was done on (b)(6) 2006 at (b)(6) hospital, (b)(6) and implant used was of depuy ref 9998-00-102, lot 2155140. First revision total hip replacement was performed on (b)(6) 2014 at (b)(6) hospital, (b)(6) and implant used was of depuy and left leg shortened by 5cm. Due to dislocation of implant second reverse thr done on (b)(6) 2014 at (b)(6) hospital (b)(6). As severe infection and watery discharge from operated area again she underwent removal of thr implant, debridement and antibiotic spacer insertion on (b)(6) 2015 at (b)(6) hospital (b)(6). Again infection and watery discharge from operated area she was admitted and surgery done on (b)(6) 2016 revision left thr for infection at (b)(6) hospital, (b)(6). Due to continuous pressure on right leg her knee of right leg pain started and knee replacement had to be done on (b)(6) 2018. As of now she is bedridden mentally disturbed and dependent physically and mentally on all family members for all day to day work.
 
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Brand NameTAPER SLEEVE ADAPTER 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 anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8816240
MDR Text Key151892959
Report Number1818910-2019-99037
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999800102
Device Lot Number2156140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2006
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: 07/23/2019 Patient Sequence Number: 1
Treatment
CREATED IN ERROR
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