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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-70-009
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Muscular Rigidity (1968); No Code Available (3191)
Date of Event 06/05/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised to address stiffness.Femur, insert and tibial were all removed.No surgical delay.Doi: (b)(6) 2018, dor: (b)(6) 2020, left knee.
 
Additional 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.H10 additional narrative: added: h6 (patient code).
 
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Brand Name
ATTUNE FB TIB BASE SZ 9 CEM
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10165132
Report Number1818910-2020-14039
Device Sequence Number3731986
Product Code JWH
UDI-Device Identifier10603295492115
UDI-Public10603295492115
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K101433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/05/2020
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 Model Number1506-70-009
Device Catalogue Number150670009
Device Lot Number8656678
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/05/2020
Supplement Date Received by Manufacturer07/21/2020
Initial Report FDA Received Date06/17/2020
Supplement Report FDA Received Date07/22/2020
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 FB TIB BASE SZ 9 CEM.; ATTUNE PS FB INSRT SZ 9 5MM.; ATTUNE PS FEM LT SZ 9 CEM.; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE PS FB INSRT SZ 9 5MM; ATTUNE PS FEM LT SZ 9 CEM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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