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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sepsis (2067); Tachycardia (2095); No Code Available (3191)
Event Date 12/14/2015
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 received entitled "cementless total hip replacements in sickle cell disease. " literature article entitled "cementless total hip replacements in sickle cell disease" by christopher m. Jack, et al, published by hip (14 december 2015) vol. 26, no. 2, pp186-192, doi: 10. 5301/hipint. 5000317 was reviewed for mdr reportability. This article reviews the perioperative reaction to tha implants of patients who have sickle cell disease (scd). 52 primary thas were carried out in 40 patients: $* s-rom femoral stems, 1 aml femoral stem, and 3 solutions femoral stems; 42 duraloc acetabular cups, 9 pinnacle cups, and 1 delta motion cups; 42 forte on forte acetabular liners and femoral head bearings, 10 delta on delta acetabular liners and femoral heads; and 35 total screws- 7 hips with two screws, 9 hips with no screws, and the remaining hips with one screw. The text of the article does not specify which of the following patient harms applies to which product or device. There were five cased of intraoperative femur fracture during reaming that were treated with cerclage. There were two cases of postoperative dislocation. One was treated with closed reduction and the other was treated with revision, where that patient developed postoperative pseudomonas sepsis. One patient experienced a postoperative ventricular tachycardia (vt) arrest. There were two cases of reported leg lengthening postoperatively due to bone sclerosis preventing adequate femur preparation for the stem. The article discusses the need for patients with scd to receive transfusions because of the nature of their disease process. There were no reported cases of the need for transfusions unrelated to scd or as a result of depuy products or devices. At follow-up, there were no cases of osteolysis with any of the cementless implants. There were no reports of device noise, impingement, inadequate osseointegration, nerve damage, or device fracture. Adverse event(s) related to product(s): unknown acetabular liner (2): implant dislocation: hip. Unknown acetabular head (2): implant dislocation: hip. Patient(s) reported harm(s) prior to procedure: surgical intervention, pain, fracture: intra-op (stem (3) only), sepsis, joint dislocation (cup and liner only), sepsis, tachycardia, limb asymmetry (stem only).
 
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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 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, PA 19380-0988
6107428552
MDR Report Key8908499
MDR Text Key155045572
Report Number1818910-2019-101544
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,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/06/2019
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: 08/19/2019 Patient Sequence Number: 1
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