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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 Problem Degraded (1153)
Patient Problems Foreign Body Reaction (1868); Swelling/ Edema (4577)
Event Date 08/30/2021
Event Type  Injury  
Event Description
Asr claim and medical records received. After review of the medical records, the patient was revised to address failed left thr with placement of dual mobility component. Operative note reported a large amount of clear to slightly yellow tinted fluid within the joint. There was corrosion of mild degree at the trunnion of the femoral component and femoral prosthetic head. Doi: (b)(6) 2009; dor: (b)(6) 2021 left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. 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 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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14166526
MDR Text Key289735059
Report Number1818910-2022-07182
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2014
Device Catalogue Number999800312
Device Lot Number2824296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2009
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: 04/21/2022 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; CORAIL AMT COLLAR SIZE 9
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