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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Code Available (3191); No Code Available (3191)
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.
 
Event Description
Literature article entitled, ¿metal-on-metal total hip arthroplasty at five to twelve years follow-up: a concise follow-up of a previous report,¿ by j. Greiner, bs, j. Callahan, md, n. Bedard, md, s. Liu, md, d. Goetz, md, and c. Mahoney, md published in the journal of arthroplasty (2016) vol. 31 pp. 1773-1778 was reviewed for mdr reportability. This article is a follow-up of a previous longitudinal analysis of the long-term results of 169 metal-on-metal (mom), cementless modular acetabular component total hip arthroplasties 5-12 years after primary surgery. Between years 5 and 12, the study identifies 7 patients who received revision surgery. All 7 patients (5 females and 2 males) showed signs of adverse local tissue reactions. Six patients had varying degrees of radiographically confirmed osteolysis: 3 cases of acetabular osteolysis and 3 cases of femoral osteolysis. Three patients had elevated serum ion levels. One pseudotumor was found intraoperatively. One patient had a hip dislocation and two hips had corrosion at the head/neck junction. None of the acetabular components had migrated and none of the removed acetabular liners showed signs of corrosion or malpositioning. None of the femoral stems underwent revision. The study mentions radiographic osteolysis that was no confirmed intraoperatively. The study identifies five patients who died during the research period, but the tha is not identified as a causative factor in any death. Longitudinal evaluation demonstrated increased rates of altr and osteolysis at longer-duration follow up. Additionally, the authors conclude that the mom bearings are inferior to the metal-on-polyethylene bearings when utilizing the same acetabular cup. Hip number 1 was revised for iliopsoas tendonitis.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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, IN 19380-0988
6103142063
MDR Report Key8854746
MDR Text Key153081167
Report Number1818910-2019-99859
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 07/30/2019
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received08/21/2019
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: 08/02/2019 Patient Sequence Number: 0
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