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 IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY
  • 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 IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1547-08-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Date of Event 10/22/2020
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
Clinical notification received for revision of left total knee to address infection as a consequence of periprosthetic joint infection; septic multi organ failure due to acute periprosthetic joint infection of the left knee and empyema of the right knee and left shoulder date of implantation: (b)(6) 2019, date of revision: (b)(6) 2020, (left knee).
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: product description: attune dist fem aug sz 8 4mm, product code: 154708001, and lot number: ht0196.1) quantity manufactured: 16, 2) date of manufacture: 4/23/2018, 3) any anomalies or deviations identified in dhr: na, 4) expiry date: 3/31/2028, and 5) ifu reference: 090200873 rev b.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE DIST FEM AUG SZ 8 4MM
Common Device Name
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10831714
Report Number1818910-2020-24508
Device Sequence Number1720604
Product Code JWH
UDI-Device Identifier10603295382850
UDI-Public10603295382850
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K160700
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional,s
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/30/2020
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? No
Operator of Device Health Professional
Device Model Number1547-08-001
Device Catalogue Number154708001
Device Lot NumberHT0196
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2020
Supplement Date Received by Manufacturer12/10/2020
Initial Report FDA Received Date11/12/2020
Supplement Report FDA Received Date12/10/2020
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
ATTUNE CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 16X80MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 12MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE MEDIAL DOME PAT 41MM; ATUNE REV RP TIB BASE SZ 8 CEM; REFOBACIN CEMENT:47115003963/814CA09175; REFOBACIN CEMENT:47115003963/814CA09175
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
Patient Weight87
-
-