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 SUMMIT BASIC CEMENTED SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM
  • 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 SUMMIT BASIC CEMENTED SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-06-100
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 05/22/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that the patient was revised to a total hip.It was also indicated that the stem was loose at cement to implant interface.Cement manufacturer is unknown.Doi: unknown; dor: (b)(6) 2020; affected side: unknown.
 
Additional Manufacturer 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.H6 patient code: no code available (3191) used to capture the insufficient information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUMMIT BASIC CEMENTED SZ 4
Common Device Name
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10114030
Report Number1818910-2020-13084
Device Sequence Number19294710
Product Code JDI
UDI-Device Identifier10603295059776
UDI-Public10603295059776
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K023453
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/22/2020
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
Operator of Device Health Professional
Device Model Number1570-06-100
Device Catalogue Number157006100
Device Lot NumberD19031978
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/22/2020
Supplement Date Received by Manufacturer07/17/2020
Initial Report FDA Received Date06/03/2020
Supplement Report FDA Received Date07/17/2020
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
ARTICUL/EZE BALL 28 +1.5 GR; CEMENTRALIZER 9.25MM; SELF CENT HIP 48X28 BRN; SUMMIT BASIC CEMENTED SZ 4; UNKNOWN BONE CEMENT; ARTICUL/EZE BALL 28 +1.5 GR; CEMENTRALIZER 9.25MM; SELF CENT HIP 48X28 BRN; SUMMIT BASIC CEMENTED SZ 4; UNKNOWN BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
-
-