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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL Back to Search Results
Model Number 1504-01-107
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Adhesion(s) (1695); Pain (1994)
Date of Event 06/22/2021
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
It was reported that the patient was involved in an mvc and started having unexplained pain.All components were removed.The components were well fixed but did have some fibrous ingrowth on some parts.Doi: (b)(6) 2020; 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 FEM POR CR LT SZ 7
Common Device Name
ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12159073
Report Number1818910-2021-15041
Device Sequence Number3989230
Product Code JWH
UDI-Device Identifier10603295041368
UDI-Public10603295041368
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
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,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/22/2021
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 Number1504-01-107
Device Catalogue Number150401107
Device Lot Number9260996
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/22/2021
Supplement Date Received by Manufacturer08/12/2021
Initial Report FDA Received Date07/13/2021
Supplement Report FDA Received Date08/13/2021
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 CR RP INSRT SZ 7 5MM.; ATTUNE FEM POR CR LT SZ 7.; ATTUNE RP TIB BASE SZ 7 POR.; ATTUNE CR RP INSRT SZ 7 5MM; ATTUNE FEM POR CR LT SZ 7; ATTUNE RP TIB BASE SZ 7 POR
Outcome Attributed to Adverse Event Required Intervention;
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