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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-50-808
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fever (1858); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 04/13/2021
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
Stage 1 revision of right attune total knee to treat pain, fever, and swelling secondary to infection.Surgery performed to remove implants, debridement and insertion of cement spacers.Doi: (b)(6) 2019.Dor: (b)(6) 2021; right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE PS RP INSRT SZ 8 8MM
Common Device Name
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11712189
Report Number1818910-2021-08499
Device Sequence Number3765404
Product Code NJL
UDI-Device Identifier10603295052876
UDI-Public10603295052876
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 04/13/2021
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 Number1516-50-808
Device Catalogue Number151650808
Device Lot Number8137337
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/13/2021
Supplement Date Received by Manufacturer07/07/2021
Initial Report FDA Received Date04/22/2021
Supplement Report FDA Received Date07/08/2021
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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
Outcome Attributed to Adverse Event Required Intervention;
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