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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
Model Number 1516-20-508
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Edema (1820); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event 12/17/2018
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
Patient communication received.It was reported that patient had a total knee on (b)(6) 2018, had a revision on (b)(6) 2018 due to wobbling, swelling and pain.Doi: (b)(6) 2018; dor: (b)(6) 2018 (unknown side).
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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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 Key9829598
Report Number1818910-2020-07782
Device Sequence Number726956
Product Code JWH
UDI-Device Identifier10603295045670
UDI-Public10603295045670
Combination Product (Y/N)N
Initial Reporter StateFL
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 consumer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/23/2019
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 Expiration Date12/31/2022
Device Model Number1516-20-508
Device Catalogue Number151620508
Device Lot NumberHN7595
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/25/2020
Supplement Date Received by Manufacturer09/25/2020
Initial Report FDA Received Date03/13/2020
Supplement Report FDA Received Date09/30/2020
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 CR FB INSRT SZ 5 8MM; ATTUNE CR FEM RT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE CR FEM RT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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