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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-124
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 03/12/2021
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 was revised due to unstable knee.Doi: unknown dor: (b)(6) 2021 left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was 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.
 
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Brand Name
ATTUNE PS FEM LT SZ 4 NAR CEM
Type of Device
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11567966
MDR Text Key242199880
Report Number1818910-2021-06058
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041696
UDI-Public10603295041696
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1504-10-124
Device Catalogue Number150410124
Device Lot Number9270718
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE RP TIB BASE SZ 3 CEM; BONE CEMENT(MFG AND PRODUCT NAME UNKNOWN); ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE RP TIB BASE SZ 3 CEM; BONE CEMENT(MFG AND PRODUCT NAME UNKNOWN)
Patient Outcome(s) Required Intervention;
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