• 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 HP UNI INS SZ3 7MM RMLL AOX SIGMA KNEE INSERT

  • 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 HP UNI INS SZ3 7MM RMLL AOX SIGMA KNEE INSERT Back to Search Results
Model Number 1024-56-307
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 12/10/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Wash out and insert exchange for possible infection. Left knee. Original date of surgery was (b)(6) 2021 by dr (b)(6) at (b)(6) medical center. Doi: (b)(6) 2021. Dor: (b)(6) 2021. Left knee.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHP UNI INS SZ3 7MM RMLL AOX
Type of DeviceSIGMA KNEE INSERT
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13154457
MDR Text Key283170731
Report Number1818910-2022-00105
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1024-56-307
Device Catalogue Number102456307
Device Lot NumberJC0582
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/04/2022 Patient Sequence Number: 1
Treatment
HP UNI INS SZ3 7MM RMLL AOX
-
-