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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 Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/25/2021
Event Type  Injury  
Event Description
It was reported as " my mother (b)(6) is having her hip replaced (b)(6) 2021. Because she has issues with her depuy johnson & johnson hip put in (b)(6) 2008. I am her daughter (b)(6) and have poa. She is suffering from issues due to the hip. High cobalt and chromium levels in her blood stream which may have led to her memory issues, heart issue along with corrosion of bone and tissue muscle her doctor can explain better than i can, his name is dr. (b)(6) orthopedic surgeon at (b)(6). Nurse (b)(6). Telephone xxx-xxx-xxxx. (b)(6) i have provided the original information of when she originally had hip replace in 2008, dr. (b)(6). (b)(6). Long operative note - (b)(6) (m. D. ) - (b)(6) 2008 12:00 am pdt. Preoperative diagnosis: severe right hip pain. Postoperative diagnosis: severe right hip pain due to complete collapse of the right femoral head. Surgical procedure: right total hip arthroplasty using the depuy total hip system. Stem was summit size 4 high offset. Cup was 50 asr cup. Head was 45 mm femoral head, cobalt chrome. Neck was minus-1 neck. (b)(6). (mrn: xxxxxxx) ¿ printed at 10/19/21 10:38 am page 6 of 8. I would like to know what your company can do to compensate her for all we have been through, please respond as soon as possible. ".
 
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.
 
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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
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12746857
MDR Text Key284813420
Report Number1818910-2021-24334
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
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 Received11/29/2021
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: 11/03/2021 Patient Sequence Number: 1
Treatment
CUP WAS 50 ASR CUP; HEAD WAS 45 MM FEMORAL HEAD COBALT CHROME; NECK WAS MINUS-1 NECK; STEM WAS SUMMIT SIZE 4 HIGH OFFSET
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