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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY
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DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1549-08-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/28/2021
Event Type  Injury  
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 Description
The patient was revised to address infection.All components were extracted and a temporary abx spacer was placed.Unknown bone cement was used.No surgical delay.Doi: (b)(6) 2019; dor: (b)(6) 2021; right knee.
 
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE POS FEM AUG SZ 8 4MM
Type of Device
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12324894
MDR Text Key266667667
Report Number1818910-2021-17898
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295383123
UDI-Public10603295383123
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1549-08-001
Device Catalogue Number154908001
Device Lot NumberJ30R18
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CEMENTED STEM 14X130MM; ATTUNE CEMENTED STEM 16X130MM; ATTUNE CRS FB INSRT SZ 8 12MM; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE POS FEM AUG SZ 8 4MM; ATUNE CRS FB TIB BASE SZ 8 CEM; UNK MANUFACTURER & PRODUCT INFO; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CEMENTED STEM 14X130MM; ATTUNE CEMENTED STEM 16X130MM; ATTUNE CRS FB INSRT SZ 8 12MM; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE POS FEM AUG SZ 8 4MM; ATUNE CRS FB TIB BASE SZ 8 CEM; UNK MANUFACTURER & PRODUCT INFO
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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