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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-210
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/07/2020
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
Revision for flexion instability pcl rupture, all components revised except the patella.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.
 
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Brand Name
ATTUNE CR FEM RT SZ 10 CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9771883
Report Number1818910-2020-06451
Device Sequence Number2411196
Product Code JWH
UDI-Device Identifier10603295041252
UDI-Public10603295041252
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K101433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/07/2020
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 Number1504-00-210
Device Catalogue Number150400210
Device Lot NumberHA8162
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/07/2020
Supplement Date Received by Manufacturer03/18/2020
Initial Report FDA Received Date02/28/2020
Supplement Report FDA Received Date03/19/2020
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 FEM RT SZ 10 CEM; ATTUNE CR RP INSRT SZ 10 5MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE RP TIB BASE SZ 9 CEM; ATTUNE SOLO PINNING SYSTEM
Outcome Attributed to Adverse Event Required Intervention;
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