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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-210
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event 11/03/2020
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
It was reported that the primary implants were oversized causing pain and suspected potential osteomyelitis.Surgeon decided to take all implants out and replace.Unknown cement was used.Doi: (b)(6) 2019.Dor: (b)(6) 2020.Right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).The device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review : 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 lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE CR FEM RT SZ 10 CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10860597
Report Number1818910-2020-24916
Device Sequence Number11671035
Product Code JWH
UDI-Device Identifier10603295041252
UDI-Public10603295041252
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K101433
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
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,Followup
Report Date (Section B) 11/03/2020
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 Number1504-00-210
Device Catalogue Number150400210
Device Lot NumberJ40H24
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/03/2020
Supplement Date Received by Manufacturer11/03/2020
12/16/2020
Initial Report FDA Received Date11/18/2020
Supplement Report FDA Received Date11/24/2020
12/16/2020
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 CR RP INSRT SZ 10 5MM.; ATTUNE CR RP INSRT SZ 10 5MM.; ATTUNE CR RP INSRT SZ 10 5MM.; ATTUNE CR RP INSRT SZ 10 5MM.
Outcome Attributed to Adverse Event Required Intervention;
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