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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/26/2020
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
Patient presented with instability of lateral ligaments.On (b)(6) 2020, these revision implants were removed and replaced with implants from another company.Side: left.
 
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 reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.
 
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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 Key10242088
Report Number1818910-2020-15234
Device Sequence Number16768290
Product Code JWH
UDI-Device Identifier10603295042174
UDI-Public10603295042174
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K160700
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) 06/26/2020
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 Number1504-40-104
Device Catalogue Number150440104
Device Lot NumberJ0498M
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/26/2020
Supplement Date Received by Manufacturer07/29/2020
Initial Report FDA Received Date07/07/2020
Supplement Report FDA Received Date07/30/2020
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 CRS FEMORAL LT SZ 4 CEM.; ATTUNE CRS RP INSRT SZ 4 16MM.; ATTUNE MEDIAL DOME PAT 38MM.; ATUN FEM SLV M/L 30MM HALF POR.; ATUN TIB SLV M/L 29MM HALF POR.; ATUNE PRESSFIT STR STEM12X60MM.; ATUNE PRESSFIT STR STEM16X60MM.; ATUNE REV RP TIB BASE SZ 3 CEM.; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 16MM; ATTUNE MEDIAL DOME PAT 38MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 3 CEM
Outcome Attributed to Adverse Event Required Intervention;
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