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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 5 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 5 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-40-005
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 08/11/2020
Event Type  malfunction  
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 Description
It was reported that the surgeon noticed some debris inside the posterior hole on the lateral side of the tibia implant during primary total knee.It was noticed before applying cement to the implant, so it was not used.Another implant was opened instead and it caused a 5-minute delay.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received states that there were no adverse consequences that affected the patient.Implant was never implanted, and cement was never applied to the implant.Opened directly out of the box.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Investigation summary
=
> examination of the returned device could not confirm the reported event.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
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> ¿ product code (b)(4), work order 9317265 was manufactured on 06/november/2019.¿ 12 parts were manufactured per specification and all raw materials met specification.¿ there was two ncs recorded against this lot.O nr-0142998: this nonconformance relates to a failed scheduled calibration of du2789 attune revision tibial base m7 thread gauge from external calibration vendor inspection equipment on the (b)(6) 2020.This gauge is used within the trays value stream in building 1 of the depuy cork facility.Therefore, there may be a correlation to the failure mode.O nr-0136857: this nonconformance relates to a failed scheduled calibration of seal0010 (cig2760a) within the trays value stream cleanroom 7 building 1 of the depuy cork facility.Therefore, there is no correlation to the failure mode.¿ there were no capas associated with this lot.¿ there were no scrap parts associated with this lot.¿ there was no reprocessing associated with this lot.Product code (b)(4), work order 9317265 of quantity 12 was sterilized on (b)(6) 2019 per the sterilization certificate 78119, the sterilization cycle met the validated parameters.
 
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Brand Name
ATUNE CRS FB TIB BASE SZ 5 CEM
Type of Device
ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10443411
MDR Text Key204052062
Report Number1818910-2020-18631
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042792
UDI-Public10603295042792
Combination Product (y/n)N
PMA/PMN Number
K160700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1506-40-005
Device Catalogue Number150640005
Device Lot Number9317265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Initial Date Manufacturer Received 08/11/2020
Initial Date FDA Received08/24/2020
Supplement Dates Manufacturer Received08/20/2020
09/01/2020
11/05/2020
Supplement Dates FDA Received08/25/2020
09/08/2020
11/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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