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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK HIP
Device Problem Fracture (1260)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Renal Failure (2041); Thromboembolism (2654); 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
On 23-june-2019 literature article entitled: ¿early failure of the ultima metal-on-metal total hip replacement in the presence of normal plain radiographs¿. The study¿s objective was to review the results of the use of the ultima hybrid metal-on-metal total hip replacement. The models of prostheses used include ultima hybrid metal-on-metal total hip replacement, with a cemented polished tapered femoral component with a 28 mm diameter and a cobalt-chrome (cocr) modular head, articulating with a 28 mm cocr acetabular bearing surface secured in a titanium alloy uncemented shell. Please note, it is indicated that the shell utilized has 3 screw holes for further fixation. Cement is indicated to be competitor. The study identified the following to be adverse outcomes, patient quantity is stated if provided: 90 revision / surgical intervention, 33 loosening of the stem, acetabular component or both, 23 renal impairment, 19 dislocation, 17 periprosthetic fractures, 15 venous thromboembolism, 9 infection, 9 persistent wound leakage, 4 squeaking / clunking, 2 palpable masses because of collections of fluid, 1 implant fracture, 1 iliotibial band defect, 1 late palsy of the sciatic nerve ¿ permanent, 1 chronic renal failure, pain, cloudy fluid within joint cavities, necrotic soft tissues with avulsed tendons, denuded osteonecrotic upper femora, metal debris / metal wear / metal within surrounding tissue, reaction to metal debris / histological evidence of hypersensitivity, corrosion.
 
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Brand NameUNKNOWN HIP IMPLANT
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8792829
MDR Text Key151112544
Report Number1818910-2019-98211
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
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 06/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP
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 Received09/02/2019
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

Patient Treatment Data
Date Received: 07/16/2019 Patient Sequence Number: 1
Treatment
UNKNOWN BONE CEMENT
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