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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Naturally Worn (2988)
Patient Problems Osteolysis (2377); No Code Available (3191)
Event Date 01/17/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4). (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
The literature article entitled, 'otto aufranc award: crosslinking reduces tha wear, osteolysis, and revision rates at 15-year follow-up compared with noncrosslinked polyethylene', written by robert h. Hopper, jr. Phd, henry ho ms, supatra sritulanondha, mph, ann c. Williams bs, and charles a. Engh, jr. Md published by clinical orthopaedics and related research published online 17 january 2018 was reviewed. The purpose of the article is to compare xlpe (highly crosslinked polyethylene liners) and cpe (conventional polyethylene) to compare results for lower rate of revision for wear-related complications, a reduced wear rate, and lower frequency of osteolysis. All implants were depuy and the liners compared were marathon (xlpe) and eduron (cpe). Duraloc cups were utilized without screws. Stems were either aml, solution or prodigy. All femoral heads were cocr material. Data was compiled from 220 patients (230 hips) implanted beginning in january 1999 without provided end date. The article reports all cups and stems were well fixed. Depuy products: marathon liner (xlpe), enduron liner (cpe), duraloc cup, aml stem, solution stem and prodigy stem. Adverse events: the article provides radiographic image (figure 3) of 43 year old man who had no evidence of osteolysis at 8 year follow up but had note of proximal femoral osteolysis at 16 year follow up. No revision was performed but figure description notes liner wear rate. Cross reference with narrative description and reference to figure 3 reveals liner is marathon. Identified patient of (b)(6) year old female not revised, but noted to experience greater trochanter fracture without osteolysis. Narrative description provides identity of liner as enduron liner. Trochanter fractures post op attributed to osteolysis associated with liner wear (treated by revision of liner): both liners. Osteolysis associated with identified liner wear (treated by revision): both liners. Osteolysis associated with identified liner wear (not revised or treated): both liners.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9835400
MDR Text Key215145386
Report Number1818910-2020-08009
Device Sequence Number1
Product Code KWY
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
Report Date 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received05/01/2020
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

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