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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)
Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)
Event Date 01/05/2020
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. (b)(4).
 
Event Description
The literature article entitled, "ten-year outcomes following a cohort of asr xl total hip arthroplasties" written by gerard a. Kelly, janet c. Hill, seamus o'brien, jane mcchesney, janice dennison, michael stevenson, and david e. Beverland published by hip international accepted by publisher on 5 january 2020 was reviewed. The article's purpose is to determine the initial reasons for revision and the 10-year outcomes of the asr xl. Data was compiled from 122 depuy asr xl thas implanted in 114 patients including depuy corail stems with age range of 19-89 years. At the 10-year follow-up, 65 patients had been revised. The article does not report which components were utilized in revision cases except for one pinnacle cup in an early revision, and it is indicated that some corail stems were left in situ during revision but later revised for loosening. Table 5 reports post revision asr xl complications and re-revisions but does not indicate what products were utilized in the revision. However, any primary corail stems left in-situ from revision surgeries are included in the data compiled in table 5 and include primary corail stems that were left in situ during first revision and then later revised during re-revision for loose stem. Therefore, any adverse events from revision that are possibly related to primary corail stems and the pinnacle cup are captured also within this complaint. Depuy products: asr xl cup, asr xl femoral head, asr xl sleeve (augment), corail stem, pinnacle cup (qty 1). Adverse events: "displaced cup" 2 days post primary (treated by revision to pinnacle cup) table 1 indicates some cups in the revised group were mispositioned. Revisions to primaries components for the following reason: pain, elevated metal ions, radiographic or mri changes (no specific information provided), loose cups, loose stems. Complications post revision possibly related to corail stem and/or pinnacle cup: greater trochanteric pain syndrome (treated by injection). Paralytic ileus leading to prolonged hospital stay of 24 days post revision.
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
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)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10274389
MDR Text Key200793051
Report Number1818910-2020-15857
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
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 Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1
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