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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Muscular Rigidity (1968); Pain (1994)
Event Date 07/31/2021
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 underwent a revision of a smith & nephew uni knee to and attune primary total knee replacement on the (b)(6) 2021.The same patient had his attune primary knee replacement revised to an attune revision knee replacement today; reasons for revision as stated by the surgeon were pain, inflammation, stiffness, varus positioning of tibial component and incorrect rotation of femoral component.Doi: (b)(6) 2021, dor: (b)(6) 2021, unknown 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 MEDIAL DOME PAT 38MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12452275
MDR Text Key270771121
Report Number1818910-2021-19800
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295056690
UDI-Public10603295056690
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,foreig
Type of Report Initial,Followup
Report Date 09/03/2021
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
Device Operator Health Professional
Device Model Number1518-20-038
Device Catalogue Number151820038
Device Lot Number9421053
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received09/10/2021
Supplement Dates Manufacturer Received09/16/2021
Supplement Dates FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ 7 7MM; ATTUNE RP TIB BASE SZ 7 CEM; PALACOS; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ 7 7MM; ATTUNE RP TIB BASE SZ 7 CEM; PALACOS
Patient Outcome(s) Required Intervention;
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