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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR Back to Search Results
Catalog Number UNK HIP FEMORAL SLEEVE ASR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/02/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Legal and medical records received. After review of medical records, it was reported that the patient presents with incredible pain, weakness and limitation to physical activities. It was also noted that patient suffers from metal on metal reaction. Elevated metal ions. The patient was then revised for failed right total hip. Operative notes reported that there was a very small effusion. There was a small amount of corrosion on the trunnion. The stem was secure with an approximately 15 degrees of anteversion. X-ray reviewed which do show well fixed components, mri does show obvious effusion w/o psuedotumor. Doi: (b)(6) 2008, dor: (b)(6) 2021, right hip.
 
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Brand NameUNK HIP FEMORAL SLEEVE ASR
Type of DeviceFEMORAL 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 Key12304080
MDR Text Key265978896
Report Number1818910-2021-17552
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL SLEEVE ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/10/2021 Patient Sequence Number: 1
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