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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP ASR
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/08/2020
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.
 
Event Description
Article entitled, ¿the calpain gene is correlated with metal-on-metal hip replacement failures¿, by joseph j. Kavolus, md, mscr, alexander l. Lazarides, md, christina moore, ms, thorsten m. Seyler, md, phd, samuel s. Wellman, md, david e. Attarian, md, michael p. Bolognesi, md, benjamin a. Alman, md, published in j arthroplasty. 2021 jan;36(1):236-241. E3. Doi: 10. 1016/j. Arth. 2020. 07. 054. Epub 2020 jul 30. Pmid: 32811707, was reviewed. The authors sought to determine whether certain immunologic genotypes are predictive of the need for revision in patients with metal-on-metal (mom) total hip implants. The study identified a genetic dna single-nucleotide polymorphism (snp), kgp9316441, encoding calpain proteins associated with inflammation and macrophage activation. This snp was associated with significantly increased odds of revision for mom hip revision. Of the 32 hips in the study, 15 were revised for mom disease, and 17 were not (the asymptomatic control group). Of the 15 revised, 7 were depuy asr hips, 6 were depuy pinnacle mom hips, and two were competitor products. Of the 15 revised, 5 presented with pseudotumors, 4 with alval (aseptic lymphocyte-dominant vasculitis associated lesion), and 15 with pain¿the study did not present these symptoms by product, but all were grouped together for the reported revisions. The specific treatments and products revised for each of these revision surgeries was not provided by the authors. The study also identified evidence of osteolysis radiographically for 2 revised patients, and for 2 unrevised patients¿no treatment was specified with regards to this finding. It was also noted that all patients, whether revised or presenting as asymptomatic, had elevations of there serum cobalt metal ions, from a low of 1. 9 ug/l to 11 ug/l on the high end, and chromium metal ions from 1. 8 ug/l to 13. 5 ug/l¿and interestingly, the levels were nearly the same in both the revision and control groups. The study did not provide manufacturer data for femoral components (apart from the asr platform head and sleeve), nor did it break down the information by individual patient, such as through individual demographics¿age and gender.
 
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Brand NameUNK HIP ACETABULAR CUP ASR
Type of DeviceHIP ACETABULAR CUP
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 Key12688911
MDR Text Key284115749
Report Number1818910-2021-23410
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 Literature,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
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: 10/25/2021 Patient Sequence Number: 1
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