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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT Back to Search Results
Catalog Number UNK ATTUNE KNEE TIBIAL INSERT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 06/18/2020
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
It was reported that single stage revision was performed due to the presence of infection.Doi: unknown, dor: (b)(6) 2020, left knee.
 
Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.
 
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Brand Name
UNK ATTUNE KNEE TIBIAL INSERT
Type of Device
UNK ATTUNE KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10218921
MDR Text Key197213924
Report Number1818910-2020-14817
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE TIBIAL INSERT
Was Device Available for Evaluation? No
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANATOMIC ATTUNE PATELLA; ATTUNE PS FEM LT SZ 7 CEM; SZ 5 FBI ATTUNE TIBIA; SZ 7 FB ATTUNE POLY; ANATOMIC ATTUNE PATELLA; ATTUNE PS FEM LT SZ 7 CEM; SZ 5 FBI ATTUNE TIBIA; SZ 7 FB ATTUNE POLY
Patient Outcome(s) Required Intervention;
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