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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151620508
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 06/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
On (b)(6) 2018, the patient underwent a right knee polyethylene exchange due to infection and tenosynovitis.The surgeon reported the insert poly was removed and replaced with poly of similar size.The patient was implanted with depuy tibial insert and there were no complications to the procedure.Doi: (b)(6) 2016 (tibial and femoral components); doi: (b)(6) 2018 (insert); dor: (b)(6) 2018.
 
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE CR FB INSRT SZ 5 8MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9217825
Report Number1818910-2019-111069
Device Sequence Number11448052
Product Code JWH
UDI-Device Identifier10603295045670
UDI-Public10603295045670
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K101433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/30/2019
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
Operator of Device Health Professional
Device Catalogue Number151620508
Device Lot Number700681
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/30/2019
Supplement Date Received by Manufacturer11/19/2019
Initial Report FDA Received Date10/22/2019
Supplement Report FDA Received Date11/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 6 CEM; SEALANT FLOSEAL GEL; SEALANT FLOSEAL GEL; STRYKER BONE CEMENT; STRYKER BONE CEMENT; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 6 CEM; SEALANT FLOSEAL GEL; SEALANT FLOSEAL GEL; STRYKER BONE CEMENT; STRYKER BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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