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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-50-608
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/04/2017
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
Complaint description: patient was revised to address a suspected infection.The infection was not confirmed.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE PS RP INSRT SZ 6 8MM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9443530
MDR Text Key170033186
Report Number1818910-2019-121826
Device Sequence Number1
Product Code NJL
UDI-Device Identifier10603295052593
UDI-Public10603295052593
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 01/04/2017
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 Number1516-50-608
Device Catalogue Number151650608
Device Lot Number8054316
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/15/2019
Initial Date FDA Received12/10/2019
Supplement Dates Manufacturer Received03/10/2021
Supplement Dates FDA Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE RP TIB BASE SZ 6 CEM; DEPUY CMW 2 20G; DEPUY CMW 2 20G; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE RP TIB BASE SZ 6 CEM; DEPUY CMW 2 20G; DEPUY CMW 2 20G
Patient Outcome(s) Required Intervention;
Patient Age45 YR
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