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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Pain (1994)
Event Date 07/23/2021
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
Patient received an attune primary knee replacement on the (b)(6) 2019 for progressive oa following a motorcycle accident approximately 18 years prior to the primary tkr. This patient also underwent multiple other surgeries on the same knee prior to the primary tkr including a ligament stabilization and hto. She has never settled following her attune tkr, so was revised for pain and stiffness being listed as the cause of revision.
 
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Brand NameATTUNE CR FEM LT SZ 5 NAR CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
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 Key12331759
MDR Text Key266896179
Report Number1818910-2021-17997
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-00-125
Device Catalogue Number150400125
Device Lot Number8596791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2017
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: 08/17/2021 Patient Sequence Number: 1
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