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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2016
Event Type  malfunction  
Manufacturer Narrative
Product complaint # b)(4). Investigation summary
==
> no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary, no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. (b)(4).
 
Event Description
"literature article entitled, ¿the corail stem as a reverse hybrid ¿ survivorship and x-ray analysis at 10 years¿ by helge wangen, et al, published by hip international (2017), doi: 10. 5301/hipint. 5000477, was reviewed. The authors report their experience of reverse hybrid tha, using the elite plus polyethylene cemented cup together with the corail fully hydroxyapatite-coated uncemented stem and a 28-mm alumina ceramic head implanted between january 2000 to december 2003. Implanted products: corail stem, charnley elite plus cup cemented with competitor cement, and a 28-mm alumina ceramic head by ceramtech. Results: 1 two-stage revision for early postoperative infection. 2 early infections treated with surgical debridement. 2 infections treated with debridement and cup revision. 1 heterotopic ossification treated with excision of the heterotopic bone and component retention. 1 periprosthetic fracture treated with stem revision. 1 cup scheduled for revision due to aseptic loosening. There is insufficient information within the text of the article to attribute the loosening to the cup that cemented with competitor cement. 1 cup loosening due to infection not revised because of patient refusal. 1 stem mispositioned into varus due to undersized stem. 2 stems identified as too small- not revised. There were noted cases of acetabular and femoral radiolucent lines that required no intervention and were not progressive. Captured in this complaint: elite plus cup- implant loosening due to infection; femoral head- no reported product problem; corail stem- mispositioned and implant fit: too small. Patient harms: infection, extraskeletal ossification, fracture post-op, surgical intervention, and medical device removal. ".
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9376037
MDR Text Key184382420
Report Number1818910-2019-117982
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
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 Received11/25/2019
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

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