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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 29MM HALF POR; KNEE TIBIAL TRAY ACCESSORY
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DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 29MM HALF POR; KNEE TIBIAL TRAY ACCESSORY Back to Search Results
Model Number 1511-11-101
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/10/2021
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
The patient's knee was revised to address loosening of the tibial component at the unknown interface.Cement manufacturer unknown.Original implant date unknown.No delay in surgery.Doi: unk, 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 no lot information available.
 
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Brand Name
ATUN TIB SLV M/L 29MM HALF POR
Common Device Name
KNEE TIBIAL TRAY ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11367125
Report Number1818910-2021-03697
Device Sequence Number16422078
Product Code NJL
UDI-Device Identifier10603295419624
UDI-Public10603295419624
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
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) 02/10/2021
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? Yes
Operator of Device Health Professional
Device Model Number1511-11-101
Device Catalogue Number151111101
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/10/2021
Supplement Date Received by Manufacturer03/31/2021
Initial Report FDA Received Date02/23/2021
Supplement Report FDA Received Date04/01/2021
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 RP INSRT SZ 5 18MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; ATTUNE CRS RP INSRT SZ 5 18MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 3 CEM
Outcome Attributed to Adverse Event Required Intervention;
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