Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-42-000
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes Pain (1994); Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 09/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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 will be filed as appropriate.
 
Event or Problem Description
Voluntary report received under mw5097267.It was reported that the patient suffered a subcapital fracture of her right hip.Bipolar hip placed in 2020.The bipolar hip assembly failed and was removed on 2020.It was replaced with another device.The second device failed and was replaced in 2020.Doi: (b)(6) 2020.Dor: (b)(6) 2020; affected side: right hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SELF CENT HIP 42X28 RUST
Common Device Name
HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10992434
Report Number1818910-2020-26813
Device Sequence Number10938266
Product Code KWY
UDI-Device Identifier10603295003328
UDI-Public10603295003328
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K812672
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1035-42-000
Device Catalogue Number103542000
Device Lot NumberHP7295
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/26/2020
Supplement Date Received by Manufacturer01/27/2021
01/27/2021
Initial Report FDA Received Date12/11/2020
Supplement Report FDA Received Date02/01/2021
02/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ARTICULEZE M 28MM 1.5; ARTICULEZE M 28MM 1.5
Outcome Attributed to Adverse Event Required Intervention;
-
-