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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number UNK HIP ACET. POLY/METAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Pain (1994); Osteolysis (2377); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device was used for treatment, not diagnosis. Pma/510k: this report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown. (b)(4).
 
Event Description
A literature article was received entitled: "is bipolar hemiarthroplasty a reliable option for ficat stage iii osteonecrosis of the femoral head? 15- to 24-year follow-up study", by kyu-tae hwang, et. Al, published in arch orthop trauma surg (2012) 132:1789¿1796. The study sought to determine reliability of bipolar hemiarthroplasty as a treatment for osteonecrosis of the femoral head. The depuy self-centering bipolar device was used on all 55 hips, paired with either a depuy trilock femoral stem (32 hips) or a depuy gemini femoral stem (23 hips), and an appropriate depuy metal femoral head, for a metal on polyethylene bearing in all hips. Ten hips were revised over the length of the study: two hips were revised for groin pain, associated with loss of acetabular cartilage and osteolysis, and the other eight were revised to address groin pain with superomedial migration of the cup with acetabular protrusion (erosion) and osteolysis. There were no reports of dislocation, stem loosening, or infection. The authors did not provide any case/patient specific accounts, nor any specific product or lot code information for any of the implanted products. This report addresses ten instances involving this product.
 
Manufacturer Narrative
(b)(4). Literature article review. No device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNKNOWN HIP ACETABULAR POLY/METAL HEMI
Type of DeviceHIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key8522380
MDR Text Key142197559
Report Number1818910-2019-90872
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACET. POLY/METAL
Device Lot NumberUNKNOWN
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 Received05/09/2019
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

Patient Treatment Data
Date Received: 04/17/2019 Patient Sequence Number: 1
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