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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 4 CEM; KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 4 CEM; KNEE FEMORAL Back to Search Results
Model Number 1504-40-104
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Edema (1820); Joint Dislocation (2374); No Code Available (3191)
Date of Event 02/21/2020
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
Clinical adverse event received for left knee dislocation (due to ligament laxity due to swelling and lymphedema).Event is serious and is considered moderate.Event is definitely related to both device and procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020.(left knee).Treatment: closed reduction / manipulation.
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).Additional information was received on 05 mar 2020 that indicates a surgical intervention and revision of the attune crs rp insrt sz 4 8mm took place on (b)(6) 2020.Only the insert was revised.Therefore, this follow-up medwatch is being submitted as a correction to indicate that the subject of this medwatch, attune crs femoral lt sz 4 cem, was reported in error.
 
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Brand Name
ATTUNE CRS FEMORAL LT SZ 4 CEM
Common Device Name
KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9843071
Report Number1818910-2020-08290
Device Sequence Number743382
Product Code JWH
UDI-Device Identifier10603295042174
UDI-Public10603295042174
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K160700
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/05/2020
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? Yes
Operator of Device Health Professional
Device Model Number1504-40-104
Device Catalogue Number150440104
Device Lot NumberJ0498R
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/27/2020
Supplement Date Received by Manufacturer03/05/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date03/23/2020
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 CRS FEMORAL LT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE POS FEM AUG SZ 4 8MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; UNK CEMENT COMPETITOR; UNK CEMENT COMPETITOR
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
Patient Weight138
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