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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 7 4MM; KNEE FEMORAL ACCESSORY
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DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 7 4MM; KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1547-07-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event 07/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 of left attune revision total knee replacement.Patient underwent revision of left total knee replacement on (b)(6) 2021 to attune revision prosthesis, rp with stems and sleeves to both the tibia and femur.The patient has an underlying condition called charcot-marie-tooth disorder.Patient presented back to surgeon with instability and hyperextension of his left knee.Procedure performed today was revision of left attune revision prosthesis to lps distal femoral replacement.The tibial construct was assessed to be stable and was not revised.The femoral construct of femur, sleeve and stem was revised and a distal femoral replacement prosthesis was inserted.Doi: (b)(6) 2021.Dor: (b)(6) 2021, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE DIST FEM AUG SZ 7 4MM
Common Device Name
KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12390908
Report Number1818910-2021-18945
Device Sequence Number4724538
Product Code JWH
UDI-Device Identifier10603295382812
UDI-Public10603295382812
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/19/2021
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 Number1547-07-001
Device Catalogue Number154707001
Device Lot NumberJ19A96
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/19/2021
Supplement Date Received by Manufacturer09/08/2021
Initial Report FDA Received Date08/31/2021
Supplement Report FDA Received Date09/09/2021
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 7 CEM; ATTUNE CRS RP INSRT SZ 7 24MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 8 CEM; COMPETITOR CEMENT; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 24MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 8 CEM; COMPETITOR CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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