• 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 MODULAR CATHCART BALL 46MM OD; HEMI HIP IMPLANT : HIP ACETABULAR 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 MODULAR CATHCART BALL 46MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI Back to Search Results
Model Number 1363-46-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 04/22/2020
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
It was reported that the patient had chronic dislocation.Doi: (b)(6) 2020, dor: (b)(6), 2020; left hip.
 
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (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 report, a follow-up report will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MODULAR CATHCART BALL 46MM OD
Type of Device
HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10025605
MDR Text Key189902703
Report Number1818910-2020-11673
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032786
UDI-Public10603295032786
Combination Product (y/n)N
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/22/2020
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
Device Operator Health Professional
Device Model Number1363-46-000
Device Catalogue Number136346000
Device Lot NumberD17110115
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/05/2020
Supplement Dates Manufacturer Received06/10/2020
Supplement Dates FDA Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TAPERED SPACER ARTICUL/ EZE +0; TAPERED SPACER ARTICUL/ EZE +0
Patient Outcome(s) Required Intervention;
Patient Age94 YR
-
-