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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-60-008
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Date of Event 10/22/2020
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
Clinical notification received for revision of left total knee to address infection as a consequence of periprosthetic joint infection; septic multi organ failure due to acute periprosthetic joint infection of the left knee and empyema of the right knee and left shoulder.Date of implantation: (b)(6) 2019; date of revision: (b)(6) 2020; (left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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 lot : dhr review: product code 150660008, work order (b)(4) was manufactured on 08-jul-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.There was no scrap associated with this lot.No reprocessing associated with this lot.Sterile cert review: product code 150660008, work order (b)(4) of quantity 15 was sterilized on 12-jul-18 as per sterilization certificate 66817, the sterilization cycle met the validated parameters.Non-conformance review there was one nc associated with this lot.Not relevant to complaint.Nr-0098567¿ this nc relates to visual aberration with laser clocking lines.Clocking lines for rp & fb revision have shifted in the x-direction causing some of the clocking to be out of specification per drawing 1150660007.There is no correlation with this nc and the failure mode.Expiry date: 30-june-2028 ifu reference: 090200876.Due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.
 
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Brand Name
ATUNE REV RP TIB BASE SZ 8 CEM
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10831787
Report Number1818910-2020-24507
Device Sequence Number16574217
Product Code NJL
UDI-Device Identifier10603295042921
UDI-Public10603295042921
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional,s
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/30/2020
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 Number1506-60-008
Device Catalogue Number150660008
Device Lot Number8853911
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2020
Supplement Date Received by Manufacturer12/17/2020
Initial Report FDA Received Date11/12/2020
Supplement Report FDA Received Date12/18/2020
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 CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 16X80MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 12MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE MEDIAL DOME PAT 41MM; REFOBACIN CEMENT:47115003963/814CA09175; REFOBACIN CEMENT:47115003963/814CA09175
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
Patient Weight87
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