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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP POLY ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP POLY ACETABULAR CUPS Back to Search Results
Catalog Number UNK HIP POLY ACETABULAR CUPS
Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374); Impaired Healing (2378); 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
An literature article was received entitled "the angle-bore acetabular component and dislocation after revision of a failed total hip replacement¿. The article was reviewed on 29-may-2019 for mdr reportability. The purpose of the study was to determine if the angle-bore socket helps reduce dislocations after previous revisions. The study included 1039 patients that had been previously revised and had a depuy angle-bore socket placed. The cement, stem, and femoral head used are all unknown at this time. The complications/revisions experienced and number of patients involved are noted below that involve the angle-bore socket. Post op complications: delayed wound healing (37), deep infection (17), pe (non-fatal) (36), cardiovascular (16), dislocation-both early and late (95). Revisions: infection (27), dislocation (22), loose angle bore socket (8), loose femoral acetabular component (46) was also noted, but its unknown at this time what the author was indicating to be loose.
 
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Brand NameUNKNOWN HIP POLY ACETABULAR CUPS
Type of DeviceHIP POLY ACETABULAR CUPS
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 Key8708518
MDR Text Key148326787
Report Number1818910-2019-96196
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 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP POLY ACETABULAR CUPS
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 Received08/02/2019
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: 06/18/2019 Patient Sequence Number: 1
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