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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 Off-Label Use (1494); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 07/18/2017
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, "cementing constrained liners into secure cementless shells: a minimum 15-year follow-up study" written by grant h. Young, bs, matthew p. Abdel, md, richard l. Amendola, be, ms, devon d. Goetz, md, david g. Lewallen, md, and john j. Callaghan, md published by the journal of arthroplasty available online 18 july 2017. The article's purpose was to determine the durability of a cementless acetabular fixation in total hip arthroplasty construct at minimum 15 year follow up. Data was compiled from 30 patients with 31 hips performed between december 1, 1988 and october 30, 2000. It is noted that non-depuy constrained poly liners were cemented into depuy (quantity 1) and non depuy cups (remainder). Therefore, it is assumed that all other components such as femoral components were non-depuy. Cement manufacturer was not identified. The article does not specify which products are related to the adverse events. Most of the adverse events involved the non-depuy products (broken constraining ring, disassociated liner, dislocation, loose stem) with the exception of one case of infection. Depuy product: quantity 1 duraloc trispike cup. Adverse event: infection (treated by revision).

 
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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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9638803
MDR Text Key177400719
Report Number1818910-2020-03275
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received03/10/2020
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

Patient TREATMENT DATA
Date Received: 01/28/2020 Patient Sequence Number: 1
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